Three‑Day versus Seven‑Day Antibiotic Treatment with doxycycline, amoxicillin and ceftriaxone in adults with mild leptospirosis

2 1 1 1

What is this study about?

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.

1 registration and randomization

after agreeing to join the study, your personal information is recorded and a unique study number is assigned. the study staff randomly assigns you to receive either a 3‑day or a 7‑day course of antibiotic treatment.

2 baseline assessment

before starting medication, a brief medical history is taken, a physical examination is performed, and blood samples are collected to confirm mild leptospirosis and to evaluate kidney, liver and blood cell function.

3 start of antibiotic therapy

on the first day you receive the assigned antibiotic:

doxycycline 200 mg given once daily either as an intravenous solution (vibraveineuse) or as an oral film‑coated tablet (doxycycline arrow 100 mg).

amoxicillin 3 g given once daily either as an intravenous solution (amoxiciline panpharma 1 g powder for injection) or as an oral dispersible tablet (clamoxyl 1 g).

ceftriaxone 1 g given once daily as an intravenous injection (rocephine 1 g/10 ml).

the specific antibiotic and route are chosen by the treating physician based on clinical judgment. you take the medication once each day for the assigned period of either 3 days or 7 days.

4 daily monitoring during treatment

while you are receiving the antibiotic, nurses check your temperature, blood pressure, heart rate and any symptoms such as headache, muscle pain or nausea each day.

if you experience any side effects, such as rash, diarrhea or a sudden rise in temperature (known as a jarisch‑herxheimer reaction), the study staff records them and provides appropriate care.

5 completion of antibiotic course

at the end of the assigned 3‑day or 7‑day period, you stop taking the study antibiotic. you may be discharged from the hospital if your condition is stable and no complications are observed.

6 follow‑up visit at day 7

seven days after the first dose of antibiotic, you return for a follow‑up visit.

the study team measures your temperature, asks about any new symptoms, and repeats blood tests to check kidney, liver and blood cell function.

the visit determines whether treatment failure has occurred, which includes persistent fever, worsening organ function or other serious complications.

7 follow‑up visit at day 21

twenty‑one days after the start of antibiotic therapy, a second follow‑up visit is scheduled.

clinical signs such as jaundice, nausea, abdominal pain, muscle aches or joint pain are assessed, and laboratory results are reviewed to confirm return to normal.

you complete a quality‑of‑life questionnaire (eq5d) to evaluate how you feel overall.

8 final data collection and study completion

after the day‑21 visit, all study data are entered into the trial database.

no further visits are required unless you develop new symptoms, in which case you should seek usual medical care.

Who Can Join the Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De La Reunion St Denis France
CHU De Martinique Fort De France France
Centre Hospitalier De Cayenne Cayenne France
Centre Hospitalier Universitaire De La Reunion Saint Pierre France
Cmqxgi Hahrxfgtyeb Uwgidluldnobg ds lx Gmyxromsie Pointe A Pitre France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
09.11.2026

Trial locations

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.

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 ID:
2024-518027-30-00
Protocol code:
19_RIPH1_07
NCT ID:
NCT04211649
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of mirikizumab and tirzepatide for adults with moderate to severe Crohn’s disease who are overweight or obese

    Recruiting

    3 1
    Investigated Drugs:
    Austria Belgium Bulgaria Czechia Denmark France +9
  • Study of MK-1084 and Pembrolizumab for First-Line Treatment in Patients with Metastatic Non-Small Cell Lung Cancer with KRAS G12C Mutation and High PD-L1 Levels

    Recruiting

    3 1 1
    Investigated Drugs:
    Austria Bulgaria France Germany Greece Italy +4