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

NCT03765931 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2018-12-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-01-31
Completion
2017-10-31

Countries

  • Senegal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03765931 on ClinicalTrials.gov