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

• ClinicalTrials.gov Identifier: NCT03765931
• Recruitment Status: Completed
• First Posted: December 5, 2018
• Last Update Posted: December 5, 2018
• Sponsor: Institut de Recherche pour le Developpement
• Information provided by (Responsible Party): Aldiouma Diallo, Institut de Recherche pour le Developpement

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fever	Drug: Doxycycline; Drug: Amoxicillin	Phase 4

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 274 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: We aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: July 2016
• Actual Primary Completion Date: January 2017
• Actual Study Completion Date: October 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: subjects treated with doxycycline; The participants treated by doxycycline 100 mg will have one dose but followed 5 days	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.
Placebo Comparator: subjects treated with amoxycilline; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of follow-up [ Time Frame: 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%.

Eligibility Criteria

• Ages Eligible for Study: 8 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Participants over 8 years with no malaria fever

Exclusion Criteria:

Under 8 years Pregnanants women

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Contacts and Locations

Locations

Senegal

Niakhar observational site

Niakhar, Fatick, Senegal

Sponsors and Collaborators

Institut de Recherche pour le Developpement

More Information

• Responsible Party: Aldiouma Diallo, MD, Institut de Recherche pour le Developpement
• ClinicalTrials.gov Identifier: NCT03765931
• Other Study ID Numbers: NCTDOXY2016
• First Posted: December 5, 2018
• Last Update Posted: December 5, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Will share by restitution with the communuty
• Supporting Materials: Study Protocol; Clinical Study Report (CSR)
• Time Frame: Just after close out and analysing the data
• Access Criteria: Share with participants but also with the ministry of heath

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fever; Body Temperature Changes; Amoxicillin; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents