A Phase 4 interventional study of Ciprofloxacin in Meningitis, Meningococcal, sponsored by Epicentre. Completed at 1 site in Niger. Per ClinicalTrials.gov, last updated 2018-02-08.
Sponsored by Epicentre · Phase 4, Interventional, and Prevention
This study evaluates the effect of antibiotic prophylaxis with ciprofloxacin, given to the contacts of meningitis cases, on the overall attack rate of meningitis during an epidemic. One third of enrolled villages will receive standard care; in one-third of villages, household contacts of meningitis cases will be offered a single dose of oral ciprofloxacin; and in one-third of villages, the entire village will be offered a single dose of oral ciprofloxacin after the notification of the first case in the village.
Antibiotic prophylaxis is not currently recommended for contacts of cases during a meningitis epidemic in the African Meningitis Belt. Reactive vaccination campaigns are the preferred strategy for prevention during an epidemic.
A novel strain of meningococcus, Neisseria meningitidis serogroup C (NmC), began circulating in Nigeria in 2013 and caused a major epidemic with over 10 000 cases in Nigeria and Niger in 2015.
There is currently a global shortage of vaccine against NmC, and a recent WHO expert panel called for the formal evaluation of antibiotic prophylaxis as another epidemic response strategy.
When taken as a single dose, oral ciprofloxacin effectively eliminates nasopharyngeal carriage of meningococcus.
This trial aims to investigate two different antibiotic prophylaxis strategies during an epidemic of meningococcal meningitis: ciprofloxacin prophylaxis to household members of cases and village-wide prophylaxis after the notification of a case in a village. These two strategies will be compared to villages receiving standard care.
125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.
This study's enrollment of 300 is below the median of 538 across 113 interventional studies indexed under Meningitis, Meningococcal.
Browse Meningitis, Meningococcal studies →Epicentre is the lead sponsor of 49 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No chemoprevention for contacts of cases of meningitis (current standard of care) with a health promotion visit by a study nurse after the first notification of cases during the epidemic
Chemoprophylaxis with a single dose of oral ciprofloxacin for household members of reported cases of meningitis. For participants age \>12 years: 500 mg tablet; age 5-12 years: 250 mg tablet; age 1-4 years: 125 mg tablet; age 3-11 months: 100 mg (2 ml oral suspension); age \<3 months: 75 mg (1.5 ml oral suspension).
Drug: Ciprofloxacin
Chemoprophylaxis with ciprofloxacin in the setting of a village-wide distribution after the notification of the first case of meningitis in a village. For participants age \>12 years: 500 mg tablet; age 5-12 years: 250 mg tablet; age 1-4 years: 125 mg tablet; age 3-11 months: 100 mg (2 ml oral suspension); age \<3 months: 75 mg (1.5 ml oral suspension).
Drug: Ciprofloxacin
Single-dose oral ciprofloxacin
Also known as: Cipro
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.
Time frame: From enrollment of a village through study completion, an average of 3 months
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
Time frame: Prior to ciprofloxacin dosing (day 0) and at 7 days and 28 days post-ciprofloxacin dosing
Proportion of patients who received ciprofloxacin who develop meningitis
Time frame: From enrollment of a village through study completion, an average of 3 months
Plan to share: Yes — A de-identified data set can be made available after the signature of an appropriate data sharing agreement.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ciprofloxacin
Epicentre