- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03765931
Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment
December 4, 2018 updated by: Aldiouma Diallo, Institut de Recherche pour le Developpement
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
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
274
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fatick
-
Niakhar, Fatick, Senegal
- Niakhar observational site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants over 8 years with no malaria fever
Exclusion Criteria:
Under 8 years Pregnanants women
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: subjects treated with doxycycline
The participants treated by doxycycline 100 mg will have one dose but followed 5 days
|
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%.
|
7 days follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
June 20, 2018
First Submitted That Met QC Criteria
December 4, 2018
First Posted (Actual)
December 5, 2018
Study Record Updates
Last Update Posted (Actual)
December 5, 2018
Last Update Submitted That Met QC Criteria
December 4, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCTDOXY2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Will share by restitution with the communuty
IPD Sharing Time Frame
Just after close out and analysing the data
IPD Sharing Access Criteria
Share with participants but also with the ministry of heath
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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