NCT02724046

Ciprofloxacin for the Prevention of Meningococcal Meningitis

Cluster-randomized Trial to Evaluate the Impact of Ciprofloxacin for Contacts of Cases of Meningococcal Meningitis as an Epidemic Response

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Epicentre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
DRUG	Ciprofloxacin	Single-dose oral ciprofloxacin

Timeline

• Start date: 2017-04-22
• Primary completion: 2017-05-30
• Completion: 2017-06-12
• First posted: 2016-03-31
• Last updated: 2018-02-08

Locations

1 site across 1 country: Niger