Mild LeptospirosisPhase 4LEPTO3NCT04211649
Comparing Two Antibiotic Therapy Periods (3 Versus 7 Days) in Patients With Mild Leptospirosis and Seen at the Hospital in 5 French Overseas Departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte)
A Phase 4 study testing 3 days of antibiotherapy in people with Mild Leptospirosis, run by University Hospital Center of Martinique at 5 sites in 5 countries.
Trial summary
Leptospirosis is a globally distributed neglected tropical disease affecting subtropical and tropical areas, such as the Caribbean and the Indian Ocean, with favorable climatic conditions for disease transmission. It shows a strong seasonality, with epidemic potential especially after heavy rainfall. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Leptospirosis
- What is being tested?
- 3 days of antibiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Oct 2024to 1 Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years and above at the time of study inclusion
- Patient consulting at a recruiting hospital center
- Clinical and biological suspicion of leptospirosis, confirmed by serological rapid testing or PCR at most 72 hours after start of antibiotic treatment
- Affiliated or beneficiary of a social security scheme (For French Guiana, patients benefiting from State Medical Aid (AME) will be considered, in accordance with the provisions of article L1121-8-1 of the Public Health Code
- Acceptance of participation in the clinical trial and in the follow-up process at 7 and 21 days (from start of antibiotic therapy)
- Provision of a signed consent form from the study participant
Who cannot join
- Presence of one of the severity criteria appearing between the time of first patient care at the hospital and study inclusion:
- Hemodynamic failure with onset of septic shock defined by persisting hypotension requiring vasopressor amines to maintain mean arterial pressure ≥65 mm Hg and blood lactates >2 mmol/L despite adequate volume resuscitation (73)
- Hematologic failure with hemoglobin <7 g / dL requiring red blood cell transfusion (74) or platelets <20 G / L requiring platelet transfusion (75)
- Ventilatory failure defined by PaO2 / Fi O2 ratio <300 mmHg (76) or resort to mechanical ventilation
- Renal failure defined by serum creatinine > 301 μmol / L 76) or resort to renal dialysis
- Hepatic failure defined by total bilirubinemia> 101 μmol / L (76)
Show all 17Show fewer
- Heart failure (eg: ECG anomalies, myocarditis, cardiogenic shock)
- Neurologic affection such as meningitis, encephalitis, intracerebral hemorragia, stroke
- Ocular symptoms such as uveitis.
- Hemoptysis, lesional pulmonary oedema for pulmonary affection
- Hemorrhagic syndrome
- Diagnosis of another bacterial infection documented during initial patient assessment (e.g. Gram-negative bacteremia, digestive tract infection, bacterial pneumonia)
- Intake of antibiotics, active on leptospirosis, the week before clinical and biological suspicion of leptospirosis
- Leptospirosis diagnosis by PCR or serological rapid testing after the 7th day from symptom onset
- Pregnant or lactating woman, or woman of childbearing age without effective contraception
- Previous hypersensitivity to β-lactams and doxycycline or contraindication to the latter's use
- Ongoing treatment that is contraindicated with one of the study treatments
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
French Guiana1 site
Centre Hospitalier Andrée Rosemond (CH de Cayenne)
Cayenne, 97300
William Faurous, MD, 0594 39 77 99 ext. +594, fanny.abad@ch-cayenne.fr
Félix Djossou, Pr
Guadeloupe1 site
University Hospital of Guadeloupe
Pointe-à-Pitre, 97159
Elvire Couchy, Master, 0590 91 19 30 ext. +590, elvire.couchy@chu-gaudeloupe.fr
Elodie Curlier, MD
Martinique1 site
Centre Hospitalier Universitaire de Martinique
Fort-de-France, 97200
Janick Jean-Marie, Master, 0596 59 26 97 ext. +596, janick.jean-marie@chu-martinique.fr
Véronique PELONDE-ERIMME, Master, 0596 59 26 97 ext. +596, veronique.pelonde-erimee@chu-martinique.fr
Mayotte1 site
Centre Hospitalier de Mayotte
Mamoudzou, 97600
Mohamadou NIANG, MD, 02 69 61 80 00 ext. +262, m.niang@chmayotte.fr
Mohamadou NIANG, MD
Reunion1 site
Centre Hospitalier Universitaire Sud Réunion
Saint-Pierre, 97448
Antoine BERTOLOTTI, MD, 02 62 35 90 00 ext. +262, antoine.bertolotti@chu-reunion.fr
Antoine BERTOLOTTI, MD
About this study
Official title: Multicenter, Randomized, Open-label Non-inferiority Trial, Comparing Two Antibiotic Therapy Periods (3 Versus 7 Days) in Patients With Mild Leptospirosis and Seen at the Hospital in 5 French Overseas Departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte)
Leptospirosis is a globally distributed neglected tropical disease affecting subtropical and tropical areas, such as the Caribbean and the Indian Ocean, with favorable climatic conditions for disease transmission. It shows a strong seasonality, with epidemic potential especially after heavy rainfall. A recent systematic review by Costa et al. (2015) places leptospirosis among the leading zoonotic causes of morbidity and mortality worldwide, with 1.03 million cases and 58,900 deaths each year.
Leptospirosis is an important public health problem, particularly within economically vulnerable populations. It is also emerging as a health threat in new settings due to globalization and climate change. Disasters and extreme weather events are recognized to precipitate epidemics.
Read more
Clinical manifestations are highly polymorphic, ranging from an anicteric, influenza-like form to severe forms with hepato-renal or pulmonary failures which are associated with high mortality.
Antibiotic therapy should be prescribed early, as soon as leptospirosis is suspected and preferably within the first 5 days, before leptospira spread to the tissues. In the treatment of mild forms, usual antibiotics are oral amoxicillin or doxycycline for a standard treatment duration of 7 days. In hospitalized cases of leptospirosis, parenteral antibiotic therapy with ceftriaxone is often favored as first-line therapy.
The most widely used antibiotics in the French Caribbean and Indian Ocean regions are amoxicillin, doxycyclin and third generation cephalosporins such as ceftriaxone.
Research hypothesis:
The effects of shorter antibiotic therapy periods for other infectious diseases have been explored by several authors. The efficacy of short ceftriaxone treatment has been highlighted for typhoid fever or meningococcal meningitis. In a retrospective series of 21 cases, the interest of short treatment periods (3-6 days) for mild and severe leptospirosis has also been described. A minimal 3-day therapy period would seem necessary in order to biologically confirm leptospirosis diagnosis and to rule out other community-acquired infections.
Our study proposal is the conduct of a non-inferiority trial comparing a shortened antibiotic therapy period of 3 days with the standard treatment period of 7 days in patients with mild leptospirosis and seen at the hospital in 5 French overseas departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte).
Originality and innovative aspects:
To our knowledge, the efficacy of a 3-day antibiotic therapy for mild leptospirosis, as compared to the standard 7 day period, has not yet been explored.
In addition, the LEPTO3 study will be among the first clinical trials to focus on the endemic public health problem, which is leptospirosis, at a large geographical level (Caribbean and Indian Ocean regions) and to involve a high level of collaboration between medical and scientific teams of these territories.
Read the detailed description
Leptospirosis is a globally distributed neglected tropical disease affecting subtropical and tropical areas, such as the Caribbean and the Indian Ocean, with favorable climatic conditions for disease transmission. It shows a strong seasonality, with epidemic potential especially after heavy rainfall. A recent systematic review by Costa et al. (2015) places leptospirosis among the leading zoonotic causes of morbidity and mortality worldwide, with 1.03 million cases and 58,900 deaths each year.
Leptospirosis is an important public health problem, particularly within economically vulnerable populations. It is also emerging as a health threat in new settings due to globalization and climate change. Disasters and extreme weather events are recognized to precipitate epidemics.
Clinical manifestations are highly polymorphic, ranging from an anicteric, influenza-like form to severe forms with hepato-renal or pulmonary failures which are associated with high mortality.
Antibiotic therapy should be prescribed early, as soon as leptospirosis is suspected and preferably within the first 5 days, before leptospira spread to the tissues. In the treatment of mild forms, usual antibiotics are oral amoxicillin or doxycycline for a standard treatment duration of 7 days. In hospitalized cases of leptospirosis, parenteral antibiotic therapy with ceftriaxone is often favored as first-line therapy.
The most widely used antibiotics in the French Caribbean and Indian Ocean regions are amoxicillin, doxycyclin and third generation cephalosporins such as ceftriaxone.
Research hypothesis:
The effects of shorter antibiotic therapy periods for other infectious diseases have been explored by several authors. The efficacy of short ceftriaxone treatment has been highlighted for typhoid fever or meningococcal meningitis. In a retrospective series of 21 cases, the interest of short treatment periods (3-6 days) for mild and severe leptospirosis has also been described. A minimal 3-day therapy period would seem necessary in order to biologically confirm leptospirosis diagnosis and to rule out other community-acquired infections.
Our study proposal is the conduct of a non-inferiority trial comparing a shortened antibiotic therapy period of 3 days with the standard treatment period of 7 days in patients with mild leptospirosis and seen at the hospital in 5 French overseas departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte).
Originality and innovative aspects:
To our knowledge, the efficacy of a 3-day antibiotic therapy for mild leptospirosis, as compared to the standard 7 day period, has not yet been explored.
In addition, the LEPTO3 study will be among the first clinical trials to focus on the endemic public health problem, which is leptospirosis, at a large geographical level (Caribbean and Indian Ocean regions) and to involve a high level of collaboration between medical and scientific teams of these territories.
Main objective :
Compare the efficacy of a 3-day antibiotic therapy period with the standard period of 7 days in mild leptospirosis patients seen at the hospital in 5 French overseas departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte)
Secondary objectives :
- Compare the evolution of clinical and biological characteristics in the 2 groups of patients (antibiotic therapy duration 3 days versus 7 days)
- Compare lengths of hospital stay in the 2 groups of patients (antibiotic therapy duration 3 days versus 7 days)
- Examine factors linked to a potential treatment failure in patients
- Assess patient tolerance to treatment
- Conditions
- Mild Leptospirosis
- Being tested
- 3 days of antibiotherapy
- Keywords
- neglected infectious, tropical diseases, emerging diseases, mild leptospirosis, insular context, antibiotics, short treatment period, non-inferiority trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 days of antibiotherapyDrug
Reduce at 3 days of antibiotherapy for the treatment of mild leptospirosis
| Study group | Role | What they receive |
|---|---|---|
| 3 days of antibiotherapy | Experimental | The patient viewed for the first time at the hospital and suspected of leptospirosis received a probabilistic antibiotherapy Receives: Drug: 3 days of antibiotherapy |
| 7 days of antibiotherapy (Amoxycilline or Doxycycline) | No intervention | When the leptospirosis is confirmed ( PCR Leptospirosis positive) the pobabilistic antibiotherapy is switched to a prophylactic antibiotherapy with Amoxicillin or Doxycycline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
- occurrence of a complication:
- Hemodynamic failure with onset of septic shock defined by persisting hypotension requiring vasopressor amines to maintain mean arterial pressure ≥65 mm Hg and blood lactates >2 mmol/L despite adequate volume resuscitation
- hematologic failure with hemoglobin <7 g / L requiring red blood cell transfusion or platelets < 20 G / L requiring platelet transfusion
- Ventilatory failure defined by PaO2 / Fi O2 ratio <300 mmHg or resort to mechanical ventilation
- Renal failure defined by serum creatinine > 301 μmol / L or resort to renal dialysis
- Hepatic failure defined by total bilirubinemia> 101 μmol / L
- Heart failure (eg: ECG anomalies, myocarditis, cardiogenic shock)
- Neurologic affection such as meningitis, encephalitis, intracerebral hemorragia, stroke
- Ocular symptoms such as uveitis.
- Hemoptysis, lesional pulmonary oedema for pulmonary affection
- Hemorrhagic syndrome , or
Measured: 7 days from the beginning of antibiotic therapy
Treatment failure
continued fever (body temperature >38°C) 5 days after the start of antibiotic therapy, or fever reappearance (body temperature >38°C) observed 24 hours after initial apyrexia (body temperature <38°C). Both cases exclude fever due to a cause not attributable to leptospirosis infection.
Or,
Measured: 7 days from the beginning of antibiotic therapy
Treatment failure
death
Measured: 7 days from the beginning of antibiotic therapy
Secondary outcomes (15)
Evolution of clinical characteristics according to 3-day versus 7-day treatment duration
measure of body temperature
- assessment of functional signs
- no evolution of infection at 21 days from start of antibiotic therapy)
- Absence of clinical symptoms (jaundice, nausea, abdominal pain, myalgia, and arthlagia)
- Normalization of biological parameters (creatinine, bilirubin, platelets, hemoglobin)
- Quality of life criteria evaluated by the EQ5D questionnaire
Measured: 21 days
Evolution functional signs according to 3-day versus 7-day treatment duration
Assessment of functional signs
Measured: 21 days
No evolution of infection at 21 days from start of antibiotic therapy according to 3-day versus 7-day treatment duration
Absence of clinical symptoms such as jaundice, nausea, abdominal pain, myalgia, and arthlagia Normalization of biological parameters (creatinine, bilirubin, platelets, hemoglobin)
Measured: 21 days
Evolution of Quality of life according to 3-day versus 7-day treatment duration
Quality of life criteria evaluated by the EQ5D questionnaire (scale from 0 to 100 with 0 means worst imaginable health state; 100 means best imaginable health state
Measured: 21 days
Evolution of bilirubinemia values according to 3-day versus 7-day treatment duration
μmol / L
Measured: 21 days
Evolution of serum creatinine values according to 3-day versus 7-day treatment duration
μmol / L
Measured: 21 days
Evolution of hemoglobin values according to 3-day versus 7-day treatment duration
G / L
Measured: 21 days
Length of hospital stay according to 3-day versus 7-day treatment duration
Measured: 21 days
Factors associated with treatment failure : Serogroup of leptospira
Measured: 7 days
Factors associated with treatment failure : Genovar of leptospira
Measured: 7 days
Factors associated with treatment failure : quantitative leptospiremia (blood) before antibiotic treatment
quantitative leptospiremia (blood) at start of antibiotic therapy
Measured: 7 days
Factors associated with treatment failure : quantitative leptospiremia (blood) Day+3 of antibiotic treatment
quantitative leptospiremia (blood) at 3 days from start of antibiotic therapy
Measured: 3 days
Factors associated with treatment failure : Delay between symptom onset and beginning of treatment
day (unit)
Measured: From day of frist symptoms until enrollment (with a maximum of 7 days between first symptom and date of enrollement)
Factors associated with treatment failure : Presence of co-morbidities
day (unit)
Measured: From the enrollment, until followup visit 1 (Day 0+7days)
Tolerance to treatment
Tolerance to treatment assessed by the occurrence of Jarisch-Herxheimer reactions, as well as adverse event reporting based on a standardized and internationally recognized toxicity table for adults
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild LeptospirosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Guadeloupe, Centre Hospitalier de Cayenne, Centre Hospitalier Universitaire de la Réunion, Hôpital de Mayotte
- Responsible party
- Sponsor
- Investigators
- André CABIE, Professor, Study director, University Hospital of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211649
- Sponsor's protocol ID
- 19_RIPH1_07
- Other IDs
- 2024-516533-13-00
- Acronym
- LEPTO3
- Status last verified
- Jul 2024
- First submitted
- 17 Dec 2019
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open-label Non-inferiority Trial, Comparing Two Antibiotic Therapy Periods (3 Versus 7 Days) in Patients With Mild Leptospirosis and Seen at the Hospital in 5 French Overseas Departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte)
- ClinicalTrials.gov ID
- NCT04211649
- Acronym / sponsor ID
- LEPTO3 / 19_RIPH1_07
- Conditions
- Mild Leptospirosis
- Keywords
- neglected infectious, tropical diseases, emerging diseases, mild leptospirosis, insular context, antibiotics, short treatment period, non-inferiority trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- University Hospital of Guadeloupe, Centre Hospitalier de Cayenne, Centre Hospitalier Universitaire de la Réunion, Hôpital de Mayotte
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Leptospirosis is a globally distributed neglected tropical disease affecting subtropical and tropical areas, such as the Caribbean and the Indian Ocean, with favorable climatic conditions for disease transmission. It shows a strong seasonality, with epidemic potential especially after heavy rainfall. A recent systematic review by Costa et al. (2015) places leptospirosis among the leading zoonotic causes of morbidity and mortality worldwide, with 1.03 million cases and 58,900 deaths each year.
Leptospirosis is an important public health problem, particularly within economically vulnerable populations. It is also emerging as a health threat in new settings due to globalization and climate change. Disasters and extreme weather events are recognized to precipitate epidemics.
Clinical manifestations are highly polymorphic, ranging from an anicteric, influenza-like form to severe forms with hepato-renal or pulmonary failures which are associated with high mortality.
Antibiotic therapy should be prescribed early, as soon as leptospirosis is suspected and preferably within the first 5 days, before leptospira spread to the tissues. In the treatment of mild forms, usual antibiotics are oral amoxicillin or doxycycline for a standard treatment duration of 7 days. In hospitalized cases of leptospirosis, parenteral antibiotic therapy with ceftriaxone is often favored as first-line therapy.
The most widely used antibiotics in the French Caribbean and Indian Ocean regions are amoxicillin, doxycyclin and third generation cephalosporins such as ceftriaxone.
Research hypothesis:
The effects of shorter antibiotic therapy periods for other infectious diseases have been explored by several authors. The efficacy of short ceftriaxone treatment has been highlighted for typhoid fever or meningococcal meningitis. In a retrospective series of 21 cases, the interest of short treatment periods (3-6 days) for mild and severe leptospirosis has also been described. A minimal 3-day therapy period would seem necessary in order to biologically confirm leptospirosis diagnosis and to rule out other community-acquired infections.
Our study proposal is the conduct of a non-inferiority trial comparing a shortened antibiotic therapy period of 3 days with the standard treatment period of 7 days in patients with mild leptospirosis and seen at the hospital in 5 French overseas departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte).
Originality and innovative aspects:
To our knowledge, the efficacy of a 3-day antibiotic therapy for mild leptospirosis, as compared to the standard 7 day period, has not yet been explored.
In addition, the LEPTO3 study will be among the first clinical trials to focus on the endemic public health problem, which is leptospirosis, at a large geographical level (Caribbean and Indian Ocean regions) and to involve a high level of collaboration between medical and scientific teams of these territories.
Detailed description
Leptospirosis is a globally distributed neglected tropical disease affecting subtropical and tropical areas, such as the Caribbean and the Indian Ocean, with favorable climatic conditions for disease transmission. It shows a strong seasonality, with epidemic potential especially after heavy rainfall. A recent systematic review by Costa et al. (2015) places leptospirosis among the leading zoonotic causes of morbidity and mortality worldwide, with 1.03 million cases and 58,900 deaths each year.
Leptospirosis is an important public health problem, particularly within economically vulnerable populations. It is also emerging as a health threat in new settings due to globalization and climate change. Disasters and extreme weather events are recognized to precipitate epidemics.
Clinical manifestations are highly polymorphic, ranging from an anicteric, influenza-like form to severe forms with hepato-renal or pulmonary failures which are associated with high mortality.
Antibiotic therapy should be prescribed early, as soon as leptospirosis is suspected and preferably within the first 5 days, before leptospira spread to the tissues. In the treatment of mild forms, usual antibiotics are oral amoxicillin or doxycycline for a standard treatment duration of 7 days. In hospitalized cases of leptospirosis, parenteral antibiotic therapy with ceftriaxone is often favored as first-line therapy.
The most widely used antibiotics in the French Caribbean and Indian Ocean regions are amoxicillin, doxycyclin and third generation cephalosporins such as ceftriaxone.
Research hypothesis:
The effects of shorter antibiotic therapy periods for other infectious diseases have been explored by several authors. The efficacy of short ceftriaxone treatment has been highlighted for typhoid fever or meningococcal meningitis. In a retrospective series of 21 cases, the interest of short treatment periods (3-6 days) for mild and severe leptospirosis has also been described. A minimal 3-day therapy period would seem necessary in order to biologically confirm leptospirosis diagnosis and to rule out other community-acquired infections.
Our study proposal is the conduct of a non-inferiority trial comparing a shortened antibiotic therapy period of 3 days with the standard treatment period of 7 days in patients with mild leptospirosis and seen at the hospital in 5 French overseas departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte).
Originality and innovative aspects:
To our knowledge, the efficacy of a 3-day antibiotic therapy for mild leptospirosis, as compared to the standard 7 day period, has not yet been explored.
In addition, the LEPTO3 study will be among the first clinical trials to focus on the endemic public health problem, which is leptospirosis, at a large geographical level (Caribbean and Indian Ocean regions) and to involve a high level of collaboration between medical and scientific teams of these territories.
Main objective :
Compare the efficacy of a 3-day antibiotic therapy period with the standard period of 7 days in mild leptospirosis patients seen at the hospital in 5 French overseas departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte)
Secondary objectives :
- Compare the evolution of clinical and biological characteristics in the 2 groups of patients (antibiotic therapy duration 3 days versus 7 days)
- Compare lengths of hospital stay in the 2 groups of patients (antibiotic therapy duration 3 days versus 7 days)
- Examine factors linked to a potential treatment failure in patients
- Assess patient tolerance to treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 days of antibiotherapy | Experimental | Drug: 3 days of antibiotherapyThe patient viewed for the first time at the hospital and suspected of leptospirosis received a probabilistic antibiotherapy |
| 7 days of antibiotherapy (Amoxycilline or Doxycycline) | No intervention | –When the leptospirosis is confirmed ( PCR Leptospirosis positive) the pobabilistic antibiotherapy is switched to a prophylactic antibiotherapy with Amoxicillin or Doxycycline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged 18 years and above at the time of study inclusion
- Patient consulting at a recruiting hospital center
- Clinical and biological suspicion of leptospirosis, confirmed by serological rapid testing or PCR at most 72 hours after start of antibiotic treatment
- Affiliated or beneficiary of a social security scheme (For French Guiana, patients benefiting from State Medical Aid (AME) will be considered, in accordance with the provisions of article L1121-8-1 of the Public Health Code
- Acceptance of participation in the clinical trial and in the follow-up process at 7 and 21 days (from start of antibiotic therapy)
Key exclusion criteria (17 listed)
- Presence of one of the severity criteria appearing between the time of first patient care at the hospital and study inclusion:
- Diagnosis of another bacterial infection documented during initial patient assessment (e.g. Gram-negative bacteremia, digestive tract infection, bacterial pneumonia)
- Intake of antibiotics, active on leptospirosis, the week before clinical and biological suspicion of leptospirosis
- Leptospirosis diagnosis by PCR or serological rapid testing after the 7th day from symptom onset
- Pregnant or lactating woman, or woman of childbearing age without effective contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 days of antibiotherapyReduce at 3 days of antibiotherapy for the treatment of mild leptospirosis | Drug | 3 days of antibiotherapy |
Primary outcome
Treatment failure
Time frame: 7 days from the beginning of antibiotic therapy
- occurrence of a complication: * Hemodynamic failure with onset of septic shock defined by persisting hypotension requiring vasopressor amines to maintain mean arterial pressure ≥65 mm Hg and blood lactates >2 mmol/L despite adequate volume resuscitation * hematologic failure with hemoglobin <7 g / L requiring red blood cell transfusion or platelets < 20 G / L requiring platelet transfusion * Ventilatory failure defined by PaO2 / Fi O2 ratio <300 mmHg or resort to mechanical ventilation * Renal failure defined by serum creatinine > 301 μmol / L or resort to renal dialysis * Hepatic failure defined by total bilirubinemia> 101 μmol / L * Heart failure (eg: ECG anomalies, myocarditis, cardiogenic shock) * Neurologic affection such as meningitis, encephalitis, intracerebral hemorragia, stroke * Ocular symptoms such as uveitis. * Hemoptysis, lesional pulmonary oedema for pulmonary affection * Hemorrhagic syndrome , or
Treatment failure
Time frame: 7 days from the beginning of antibiotic therapy
continued fever (body temperature >38°C) 5 days after the start of antibiotic therapy, or fever reappearance (body temperature >38°C) observed 24 hours after initial apyrexia (body temperature <38°C). Both cases exclude fever due to a cause not attributable to leptospirosis infection. Or,
Treatment failure
Time frame: 7 days from the beginning of antibiotic therapy
death
15 secondary outcomes
Evolution of clinical characteristics according to 3-day versus 7-day treatment duration
Time frame: 21 days
Evolution functional signs according to 3-day versus 7-day treatment duration
Time frame: 21 days
No evolution of infection at 21 days from start of antibiotic therapy according to 3-day versus 7-day treatment duration
Time frame: 21 days
Evolution of Quality of life according to 3-day versus 7-day treatment duration
Time frame: 21 days
Evolution of bilirubinemia values according to 3-day versus 7-day treatment duration
Time frame: 21 days
Evolution of serum creatinine values according to 3-day versus 7-day treatment duration
Time frame: 21 days
Evolution of hemoglobin values according to 3-day versus 7-day treatment duration
Time frame: 21 days
Length of hospital stay according to 3-day versus 7-day treatment duration
Time frame: 21 days
Factors associated with treatment failure : Serogroup of leptospira
Time frame: 7 days
Factors associated with treatment failure : Genovar of leptospira
Time frame: 7 days
Factors associated with treatment failure : quantitative leptospiremia (blood) before antibiotic treatment
Time frame: 7 days
Factors associated with treatment failure : quantitative leptospiremia (blood) Day+3 of antibiotic treatment
Time frame: 3 days
Factors associated with treatment failure : Delay between symptom onset and beginning of treatment
Time frame: From day of frist symptoms until enrollment (with a maximum of 7 days between first symptom and date of enrollement)
Factors associated with treatment failure : Presence of co-morbidities
Time frame: From the enrollment, until followup visit 1 (Day 0+7days)
Tolerance to treatment
Time frame: 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
André CABIE, Professor study director
University Hospital of Martinique
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3 days of antibiotherapy in people with Mild Leptospirosis, run by University Hospital Center of Martinique at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in French Guiana, Guadeloupe, Martinique, Mayotte, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janick JEAN-MARIE, Master (0596 59 26 97 ext. +596, janick.jean-marie@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 7 days from the beginning of antibiotic therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.