FeverPhase 4NCT03765931
Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment
A Phase 4 study testing Doxycycline and Amoxicillin in people with Fever, run by Institut de Recherche pour le Developpement at 1 site in Senegal.
Trial summary
Abstract: Background The current practice in Senegal is to use broad-spectrum antibiotics including amoxicillin and/or cotrimoxazole in case of non-malarial fevers. First-line treatment with doxycycline has cured such patients. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fever
- What is being tested?
- Doxycycline and Amoxicillin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 1 siteSenegal
- Study dates
- Jul 2016to Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants over 8 years with no malaria fever
Who cannot join
- Under 8 years Pregnanants women
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment for Patients With Non-malarial Fever: a Randomized Non-inferiority Trial in Senegal
Abstract: Background The current practice in Senegal is to use broad-spectrum antibiotics including amoxicillin and/or cotrimoxazole in case of non-malarial fevers. First-line treatment with doxycycline has cured such patients. The investgators aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.
Read the detailed description
Methods The investgators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (1:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investgators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C. The investgators used a non-inferiority margin of 10%. This trial was approved by the national ethic committees of the Senegalese Ministry of Health in May 2017 (0026/MSAS/DPRS/CNERS, March, 7, 2016).
- Conditions
- Fever
- Being tested
- Doxycycline, Amoxicillin
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
The investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C.
AmoxicillinDrug
The investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C.
| Study group | Role | What they receive |
|---|---|---|
| subjects treated with doxycycline | Active comparator | The participants treated by doxycycline 100 mg will have one dose but followed 5 days Receives: Drug: Doxycycline |
| subjects treated with amoxycilline | Placebo comparator | The participants treated with amoxycilline 500 mg will have 2 doses per days during 5 days treatement and follwed during these 5 days Receives: Drug: Doxycycline; Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of follow-up
The endpoint was cure at day-7 post-inclusion. Clinical cure was defined as a body temperature < 37.5°C. Clinical failure was defined as persistence of fever > 37.5°C at day-7. The investgators used a non-inferiority margin of 10%.
Measured: 7 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study startJul 2016
- Primary completionJan 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies 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
- Model description
- We aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aldiouma Diallo, Institut de Recherche pour le Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765931
- Sponsor's protocol ID
- NCTDOXY2016
- Status last verified
- Dec 2018
- First submitted
- 20 Jun 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share by restitution with the communuty
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment for Patients With Non-malarial Fever: a Randomized Non-inferiority Trial in Senegal
- ClinicalTrials.gov ID
- NCT03765931
- Acronym / sponsor ID
- NCTDOXY2016
- Conditions
- Fever
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Study start
- Jul 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 5 Dec 2018 (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.
Abstract: Background The current practice in Senegal is to use broad-spectrum antibiotics including amoxicillin and/or cotrimoxazole in case of non-malarial fevers. First-line treatment with doxycycline has cured such patients. The investgators aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.
Detailed description
Methods The investgators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (1:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investgators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C. The investgators used a non-inferiority margin of 10%. This trial was approved by the national ethic committees of the Senegalese Ministry of Health in May 2017 (0026/MSAS/DPRS/CNERS, March, 7, 2016).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.
| Arm | Type | Receives |
|---|---|---|
| subjects treated with doxycycline | Active comparator | Drug: DoxycyclineThe participants treated by doxycycline 100 mg will have one dose but followed 5 days |
| subjects treated with amoxycilline | Placebo comparator | Drug: Doxycycline, Drug: AmoxicillinThe participants treated with amoxycilline 500 mg will have 2 doses per days during 5 days treatement and follwed during these 5 days |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants over 8 years with no malaria fever
Key exclusion criteria (2 listed)
- Under 8 years Pregnanants women
- -
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 |
|---|---|---|
| DoxycyclineThe investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C. | Drug | subjects treated with amoxycilline, subjects treated with doxycycline |
| AmoxicillinThe investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C. | Drug | subjects treated with amoxycilline |
Primary outcome
Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of follow-up
Time frame: 7 days follow up
The endpoint was cure at day-7 post-inclusion. Clinical cure was defined as a body temperature < 37.5°C. Clinical failure was defined as persistence of fever > 37.5°C at day-7. The investgators used a non-inferiority margin of 10%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: Yes. Will share by restitution with the communuty
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxycycline and Amoxicillin in people with Fever, run by Institut de Recherche pour le Developpement at 1 site in Senegal.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of follow-up (time frame: 7 days follow up). 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 5 Dec 2018.