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

NCT03765931 | Completed Phase 4 DMC

• 1 other identifier: NCTDOXY2016
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of 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%.

  7 days follow up

Study Arms (2)

subjects treated with doxycycline

ACTIVE COMPARATOR

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

Drug: Doxycycline

subjects treated with amoxycilline

PLACEBO COMPARATOR

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

Drug: Doxycycline; Drug: Amoxicillin

Interventions

Doxycycline DRUG

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.

subjects treated with amoxycilline; subjects treated with doxycycline

Amoxicillin DRUG

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.

subjects treated with amoxycilline

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants over 8 years with no malaria fever

You may not qualify if:

• Under 8 years Pregnanants women

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead

Study Sites (1)

Niakhar observational site

Niakhar, Fatick, Senegal

Location

MeSH Terms

Conditions

Fever

Interventions

Doxycycline; Amoxicillin

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: We aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: December 5, 2018
• Study Start: July 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Just after close out and analysing the data
• Access Criteria: Share with participants but also with the ministry of heath

Locations

SE (1)