Clinical trial NCT02724046: Ciprofloxacin for the Prevention of Meningococcal Meningitis
Official title: Cluster-randomized Trial to Evaluate the Impact of Ciprofloxacin for Contacts of Cases of Meningococcal Meningitis as an Epidemic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningitis, Meningococcal
Keywords: Neisseria meningitidis
Ciprofloxacin
Chemoprevention
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Medecins Sans Frontieres, Netherlands
First posted: 2016-03-31
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Meningitis Attack Rate
timeFrame: From enrollment of a village through study completion, an average of 3 months
Secondary outcomes:
measure: Proportion of participants with ciprofloxacin-resistant enterobacteriaceae in their stools
timeFrame: Prior to ciprofloxacin dosing (day 0) and at 7 days and 28 days post-ciprofloxacin dosing
measure: Proportion of patients who received ciprofloxacin who develop meningitis
timeFrame: From enrollment of a village through study completion, an average of 3 months
Other outcomes:
Locations:
city: Madarounfa
country: Niger
facility: Madarounfa Health District
state: Maradi
Study officials:
affiliation: Epicentre
name: Rebecca F Grais, PhD
role: STUDY_DIRECTOR
References:
citation: Coldiron ME, Assao B, Page AL, Hitchings MDT, Alcoba G, Ciglenecki I, Langendorf C, Mambula C, Adehossi E, Sidikou F, Tassiou EI, De Lastours V, Grais RF. Single-dose oral ciprofloxacin prophylaxis as a response to a meningococcal meningitis epidemic in the African meningitis belt: A 3-arm, open-label, cluster-randomized trial. PLoS Med. 2018 Jun 26;15(6):e1002593. doi: 10.1371/journal.pmed.1002593. eCollection 2018 Jun.
citation: Coldiron ME, Alcoba G, Ciglenecki I, Hitchings M, Djibo A, Page AL, Langendorf C, Grais RF. Ciprofloxacin for contacts of cases of meningococcal meningitis as an epidemic response: study protocol for a cluster-randomized trial. Trials. 2017 Jun 24;18(1):294. doi: 10.1186/s13063-017-2028-y.