Phase
Condition
N/ATreatment
3 days of antibiotherapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 rapidtesting or PCR at most 72 hours after start of antibiotic treatment
Affiliated or beneficiary of a social security scheme (For French Guiana, patientsbenefiting from State Medical Aid (AME) will be considered, in accordance with theprovisions of article L1121-8-1 of the Public Health Code
Acceptance of participation in the clinical trial and in the follow-up process at 7and 21 days (from start of antibiotic therapy)
Provision of a signed consent form from the study participant
Exclusion
Exclusion Criteria:
Presence of one of the severity criteria appearing between the time of first patientcare at the hospital and study inclusion:
Hemodynamic failure with onset of septic shock defined by persistinghypotension requiring vasopressor amines to maintain mean arterial pressure ≥65mm Hg and blood lactates >2 mmol/L despite adequate volume resuscitation (73)
Hematologic failure with hemoglobin <7 g / dL requiring red blood celltransfusion (74) or platelets <20 G / L requiring platelet transfusion (75)
Ventilatory failure defined by PaO2 / Fi O2 ratio <300 mmHg (76) or resort tomechanical ventilation
Renal failure defined by serum creatinine > 301 μmol / L 76) or resort to renaldialysis
Hepatic failure defined by total bilirubinemia> 101 μmol / L (76)
Heart failure (eg: ECG anomalies, myocarditis, cardiogenic shock)
Neurologic affection such as meningitis, encephalitis, intracerebralhemorragia, stroke
Ocular symptoms such as uveitis.
Hemoptysis, lesional pulmonary oedema for pulmonary affection
Hemorrhagic syndrome
Diagnosis of another bacterial infection documented during initial patientassessment (e.g. Gram-negative bacteremia, digestive tract infection, bacterialpneumonia)
Intake of antibiotics, active on leptospirosis, the week before clinical andbiological suspicion of leptospirosis
Leptospirosis diagnosis by PCR or serological rapid testing after the 7th day fromsymptom onset
Pregnant or lactating woman, or woman of childbearing age without effectivecontraception
Previous hypersensitivity to β-lactams and doxycycline or contraindication to thelatter's use
Ongoing treatment that is contraindicated with one of the study treatments
Study Design
Study Description
Connect with a study center
Centre Hospitalier Andrée Rosemond (CH de Cayenne)
Cayenne, 97300
French GuianaSite Not Available
University Hospital of Guadeloupe
Pointe-à-Pitre, 97159
GuadeloupeSite Not Available
Centre Hospitalier Universitaire de Martinique
Fort-de-France, 97200
MartiniqueSite Not Available
Centre Hospitalier de Mayotte
Mamoudzou, 97600
MayotteSite Not Available
Centre Hospitalier Universitaire Sud Réunion
Saint-Pierre, 97448
RéunionSite Not Available
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