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

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

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).

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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


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.




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%.



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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765931


Locations
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Senegal
Niakhar observational site
Niakhar, Fatick, Senegal
Sponsors and Collaborators
Institut de Recherche pour le Developpement

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Responsible Party: Aldiouma Diallo, MD, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT03765931     History of Changes
Other Study ID Numbers: NCTDOXY2016
First Posted: December 5, 2018    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fever
Body Temperature Changes
Signs and Symptoms
Amoxicillin
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents