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

French Public Scientific and Technological Institution (EPST)

Status and phase: Completed; Phase 4

Conditions: Fever

Treatments: Drug: Doxycycline; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT03765931

NCTDOXY2016

Details and patient eligibility

About

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.

Full 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).

Enrollment: 274 patients

Sex: All

Ages: 8+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants over 8 years with no malaria fever

Exclusion criteria

Under 8 years Pregnanants women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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274 participants in 2 patient groups, including a placebo group

subjects treated with doxycycline

Active Comparator group

Description:

The participants treated by doxycycline 100 mg will have one dose but followed 5 days

Treatment:

Drug: Doxycycline

subjects treated with amoxycilline

Placebo Comparator group

Description:

The participants treated with amoxycilline 500 mg will have 2 doses per days during 5 days treatement and follwed during these 5 days

Treatment:

Drug: Doxycycline

Drug: Amoxicillin