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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03431675 |
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Date of registration:
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06/02/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ciprofloxacin for the Prevention of Meningococcal Meningitis 2018
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Scientific title:
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Cluster-randomized Trial to Evaluate the Impact of Ciprofloxacin Prophylaxis as a Response to a Meningococcal Meningitis Epidemic |
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Date of first enrolment:
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March 1, 2019 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03431675 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Niger
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Contacts
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Name:
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Rebecca F GRAIS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Epicentre |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Meningitis, Meningococcal
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Intervention(s)
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Drug: Ciprofloxacin
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Primary Outcome(s)
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Meningitis attack rate
[Time Frame: From enrollment of a village through study completion, an average of 2 months]
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Secondary Outcome(s)
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Proportion of participants with ciprofloxacin-resistant enterobacteriaceae in their stools
[Time Frame: Prior to ciprofloxacin dosing (day 0) and at 7 and 28 days post-ciprofloxacin dosing]
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Proportion of patients who received ciprofloxacin who develop meningitis
[Time Frame: From enrollment of a village through study completion, an average of 2 months]
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Meningitis attack rate by age
[Time Frame: From enrollment of a village through study completion, an average of 2 months]
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Meningitis attack rate by sex
[Time Frame: From enrollment of a village through study completion, an average of 2 months]
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Secondary ID(s)
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Cipro chemoprophylaxis 2018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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