LeptospirosisPhase 2/3NCT00592566
Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis
A Phase 2/3 study testing Dexamethasone, desmopressin in people with Leptospirosis, run by Mahidol University at 1 site in Thailand.
Trial summary
Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Leptospirosis
- What is being tested?
- Dexamethasone, desmopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2003to Oct 2006
- Phase
- Phase 2/3
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult patients (> 14 years) with suspected severe leptospirosis
- patients who presented with acute fever (oral temperature more than 38.00 C for <15 days) in the absence of an obvious focus of infection
- In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration).
Who cannot join
- pregnant or breastfeeding
- those with history of bleeding disorder
- those who had underlying diseases such as chronic liver disease, diabetes mellitus
- those who received diuretic or glucocorticoid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis
Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand.
Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.
- Conditions
- Leptospirosis
- Being tested
- Dexamethasone, desmopressin
- Keywords
- Severe leptospirosis, Pulmonary hemorrhage
- Medical subject headings
- Leptospirosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone, desmopressinDrug
Also called Minirin
200 mg of dexamethasone IV infusion OD for 3 days or 0.3 microgram/ kg of desmopressin in 50 ml of saline, as a 30- minute infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Standard supportive care |
| 2 | Experimental | Dexamethasone treatment Receives: Drug: Dexamethasone, desmopressin |
| 3 | Experimental | Desmopressin treatment Receives: Drug: Dexamethasone, desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: during in hospital admission
Secondary outcomes (1)
Days of mechanical ventilation
Measured: during hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJul 2003
- Primary completionOct 2006
- Study completionOct 2006
Why it stopped: Numbe of eligible patients has been decreased over time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeptospirosisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Thailand Research Fund
- Investigators
- Kanigar Niwattayakul, MD, Principal investigator, Loei Hospital, Loei, Thailand:Yupin Suputtamongkol, MD, Study chair, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592566
- Sponsor's protocol ID
- DDP2003
- Other IDs
- RDG4630213
- Status last verified
- Dec 2007
- First submitted
- 1 Jan 2008
- Last updated
- 14 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis
- ClinicalTrials.gov ID
- NCT00592566
- Acronym / sponsor ID
- DDP2003
- Conditions
- Leptospirosis
- Keywords
- Severe leptospirosis, Pulmonary hemorrhage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Numbe of eligible patients has been decreased over time.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Thailand Research Fund
- Study start
- Jul 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 14 Jan 2008 (estimated)
- 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.
Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand.
Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Standard supportive care |
| 2 | Experimental | Drug: Dexamethasone, desmopressinDexamethasone treatment |
| 3 | Experimental | Drug: Dexamethasone, desmopressinDesmopressin treatment |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients (> 14 years) with suspected severe leptospirosis
- patients who presented with acute fever (oral temperature more than 38.00 C for <15 days) in the absence of an obvious focus of infection
- In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration).
Key exclusion criteria (4 listed)
- pregnant or breastfeeding
- those with history of bleeding disorder
- those who had underlying diseases such as chronic liver disease, diabetes mellitus
- those who received diuretic or glucocorticoid
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 |
|---|---|---|
| Dexamethasone, desmopressinAlso: Minirin200 mg of dexamethasone IV infusion OD for 3 days or 0.3 microgram/ kg of desmopressin in 50 ml of saline, as a 30- minute infusion | Drug | 2, 3 |
Primary outcome
Survival
Time frame: during in hospital admission
1 secondary outcome
Days of mechanical ventilation
Time frame: during hospital admission
Results and safety
The study was stopped early (reason given: Numbe of eligible patients has been decreased over time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2008.
Related trials for Leptospirosis
Not yet recruitingObservational study
Ex Vivo Study of Leukocyte Responses in the Blood of Patients With Leptospirosis and ex Vivo Testing of a New Host-targeted Therapeutic Strategy to Restore Phagocytosis of Leptospira
Leptospirosis, Jarisch Herxheimer Reaction
Not yet recruitingObservational study
Assessment of the Risk of Zoonotic Infections in Prisons in French Guiana
Q Fever, Leptospirosis
Not yet recruitingPhase 4
These Studies That Evaluated the Efficacy of Antibiotics for Leptospirosis Treatment.
Leptospirosis, Chemoprophylaxis
Recruiting
Leptospirosis Care Bundle Study
Leptospirosis
Active, not recruiting
Cohort of Hospitalized Patients Suspected of Leptospirosis
Leptospirosis
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.
Kanigar Niwattayakul, MD principal investigator
Loei Hospital, Loei, Thailand:
Yupin Suputtamongkol, MD study chair
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexamethasone, desmopressin in people with Leptospirosis, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Jan 2008. 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 Thailand. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Numbe of eligible patients has been decreased over time.). Results are not available in the source record.
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?
Survival (time frame: during in hospital admission). 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 14 Jan 2008.