CHU De Martinique
Fort De France, France
Not yet recruitingLeptospirosis
Three‑Day versus Seven‑Day Antibiotic Treatment with doxycycline, amoxicillin and ceftriaxone in adults with mild leptospirosis
Verified siteRegistered drug
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The study focuses on leptospirosis, a bacterial infection that can cause fever, muscle aches, jaundice and, in severe cases, organ problems. Participants have a mild form of the disease and will receive standard antibiotic therapy, which may include doxycycline, amoxicillin or ceftriaxone given by mouth or through an intravenous (IV) line.
The purpose is to compare a short 3‑day treatment course with the usual 7‑day course. After enrollment, patients are randomly assigned to receive antibiotics for either three or seven days while staying in the hospital. Throughout the treatment period and during follow‑up visits, medical staff monitor body temperature, signs of infection and any worsening of health, such as low blood pressure, breathing difficulty, kidney or liver problems, and rare complications like septic shock. The study records how quickly patients recover, any side effects, and the length of hospital stay.
The research process
The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Be at least 18 years old when you join the study.
- Visit a hospital that is taking part in the research.
- Have symptoms and lab results that suggest leptospirosis, confirmed by a quick blood test for antibodies (serological rapid test) or a test that looks for the bacteria’s genetic material (PCR) within 72 hours after you start antibiotics.
- Be covered by a social security scheme (or, in French Guiana, by State Medical Aid if you qualify).
- Agree to take part in the study and attend check‑ups at 7 days and 21 days after you begin antibiotic treatment.
- Sign a consent form that shows you understand and accept the study.
Who cannot join the trial?
1 criterion
- Not being part of, or not receiving benefits from, the social security scheme (the government program that helps cover health‑care costs and other services).
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified Verified Centre Hospitalier Universitaire De La Reunion
St Denis, FranceVerified Centre Hospitalier Universitaire de la Guadeloupe
Pointe A Pitre, France
Trial locations
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Investigated drugs
Vibraveineuse (intravenous doxycycline solution)
is an antibiotic given through a vein. In this study it is used as one of the treatment options for patients with mild leptospirosis, allowing doctors to see how well a short course of IV doxycycline works compared to a longer course.
Doxycycline Arrow (oral tablet)
is a pill form of the same antibiotic, taken by mouth. It is included in the trial to compare the effectiveness of a short 3‑day oral treatment with the usual 7‑day regimen for mild leptospirosis.
Clamoxyl (dispersible amoxicillin tablet)
is a powder that dissolves in water to make a drinkable antibiotic. This medicine is tested in the trial as an alternative oral treatment, helping researchers understand if a brief 3‑day course can control leptospirosis as well as the standard 7‑day course.
Amoxicilline Panpharma (intravenous amoxicillin solution)
is an antibiotic given directly into a vein. It is part of the study to evaluate whether a short IV course of amoxicillin is as effective as the longer standard treatment for mild leptospirosis.
Rocephine (intravenous ceftriaxone solution)
is a broad‑spectrum antibiotic administered through a vein. In this trial it serves as another IV option, allowing comparison of a 3‑day ceftriaxone regimen with the usual 7‑day therapy for patients with mild leptospirosis.
What is already known about the treatment
Doxycycline hyclate
This medication is supplied as a sterile solution for intravenous infusion, allowing it to be given directly into a vein. It is an approved and widely used antibiotic that treats many bacterial infections, including mild leptospirosis. It works by blocking the bacteria’s ability to produce proteins needed for growth. It belongs to the tetracycline class of antibiotics.
Doxycycline
This form comes as a film‑coated tablet taken by mouth. It is a well‑known, approved antibiotic used for a variety of bacterial infections such as leptospirosis. It stops bacteria from making essential proteins, which halts their growth. It is classified as a tetracycline antibiotic.
Amoxicillin
The drug is provided as a dispersible tablet that is dissolved in water and swallowed. It is an established, widely prescribed antibiotic for many common infections like ear, throat, and lung infections. It kills bacteria by interfering with the building of their cell walls, causing them to burst. It belongs to the penicillin (beta‑lactam) class of antibiotics.
Amoxicillin
This preparation is a powder that is mixed to form an injectable solution for intravenous use. It is a recognized, approved antibiotic used for serious bacterial infections when oral treatment is not suitable. It works by preventing bacteria from forming a strong cell wall, leading to their death. It is a penicillin‑type (beta‑lactam) antibiotic.
Ceftriaxone
The drug is supplied as a powder that is reconstituted into a solution for intravenous, sub‑cutaneous, or intramuscular injection. It is a globally approved third‑generation cephalosporin used for severe bacterial infections such as pneumonia and meningitis. It kills bacteria by binding to proteins that build the cell wall, causing the wall to break down. It is classified as a cephalosporin antibiotic.
Investigated diseases
leptospirosis - Leptospirosis is a bacterial infection caused by spirochetes of the genus Leptospira. It is usually acquired through contact with water or soil contaminated by the urine of infected animals. The disease often begins with fever, headache, muscle aches, and sometimes nausea. As it progresses, it can involve the kidneys, liver, and lungs, leading to changes in urine output, jaundice, or respiratory symptoms. In some cases, the infection may affect the heart or nervous system, causing irregular heartbeat or meningitis‑like signs. Symptoms typically improve within a few weeks if the infection is controlled.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518027-30-00Protocol code19_RIPH1_07Estimated enrolment304 patientsSponsorCHU De Martinique
sourced from the EU Clinical Trials Register and site verification
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