Meningitis, Meningococcal Clinical Trial
Official title:
Cluster-randomized Trial to Evaluate the Impact of Ciprofloxacin Prophylaxis as a Response to a Meningococcal Meningitis Epidemic
Verified date | August 2019 |
Source | Epicentre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The trial is an interventional, cluster-randomized trial to assess the impact of oral
ciprofloxacin for household and community contacts of meningitis cases on the incidence of
meningitis during an epidemic.
The trial contains a nested sub-study ("resistance study") to assess the effect of a single
dose of ciprofloxacin on the prevalence of fluoroquinolone-resistant enterobacteriaceae in
the study area.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Resident in a village included in the study area Exclusion Criteria: - Patients currently exhibiting symptoms of meningitis (to be immediately referred for further care) - Persons with a known allergy to fluoroquinolone antibiotics. |
Country | Name | City | State |
---|---|---|---|
Niger | Madarounfa Health District | Madarounfa | Maradi |
Lead Sponsor | Collaborator |
---|---|
Epicentre | Medecins Sans Frontieres, Netherlands |
Niger,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Meningitis attack rate | The primary outcome aims to evaluate the impact of a chemoprevention strategy as a public health intervention during a meningitis outbreak, which is best evaluated by looking at the overall attack rates in the study area. | From enrollment of a village through study completion, an average of 2 months | |
Secondary | Proportion of participants with ciprofloxacin-resistant enterobacteriaceae in their stools | A substudy is proposed to compare rates of acquisition of ciprofloxacin resistance among participants in the standard care arm and participants in the village prophylaxis arm. 20 participants in 10 villages in each of the two arms will be asked to provide stool samples on days 0, 7 and 28 | Prior to ciprofloxacin dosing (day 0) and at 7 and 28 days post-ciprofloxacin dosing | |
Secondary | Proportion of patients who received ciprofloxacin who develop meningitis | This secondary outcome aims to evaluate the impact of a chemoprevention strategy as a public health intervention during a meningitis outbreak, which is best evaluated by looking at the overall attack rates in the study area. | From enrollment of a village through study completion, an average of 2 months | |
Secondary | Meningitis attack rate by sex | This secondary outcome aims to evaluate the impact of a chemoprevention strategy as a public health intervention during a meningitis outbreak, which is best evaluated by looking at the overall attack rates in the study area. | From enrollment of a village through study completion, an average of 2 months | |
Secondary | Meningitis attack rate by age | This secondary outcome aims to evaluate the impact of a chemoprevention strategy as a public health intervention during a meningitis outbreak, which is best evaluated by looking at the overall attack rates in the study area. | From enrollment of a village through study completion, an average of 2 months |
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