NCT03765931

Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment

Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment for Patients With Non-malarial Fever: a Randomized Non-inferiority Trial in Senegal

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Institut de Recherche pour le Developpement · Other Government
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

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).

Conditions

• Fever

Interventions

Type	Name	Description
DRUG	Doxycycline	The investigators 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 (2:1) 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 investigators 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.
DRUG	Amoxicillin	The investigators 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 (2:1) 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 investigators 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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-01-01
• Completion: 2017-10-01
• First posted: 2018-12-05
• Last updated: 2018-12-05

Locations

1 site across 1 country: Senegal