Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment
- Registration Number
- NCT03765931
- Lead Sponsor
- Institut de Recherche pour le Developpement
- Brief 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. 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
- Participants over 8 years with no malaria fever
Under 8 years Pregnanants women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description subjects treated with doxycycline Doxycycline The participants treated by doxycycline 100 mg will have one dose but followed 5 days subjects treated with amoxycilline Doxycycline The participants treated with amoxycilline 500 mg will have 2 doses per days during 5 days treatement and follwed during these 5 days subjects treated with amoxycilline Amoxicillin The participants treated with amoxycilline 500 mg will have 2 doses per days during 5 days treatement and follwed during these 5 days
- Primary Outcome Measures
Name Time Method Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of follow-up 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%.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Niakhar observational site
🇸🇳Niakhar, Fatick, Senegal