Ciprofloxacin for the Prevention of Meningococcal Meningitis

Epicentre

Status and phase: Completed; Phase 4

Conditions: Meningitis, Meningococcal

Treatments: Drug: Ciprofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02724046

Ciprofloxacin chemoprophylaxis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Standard care

No Intervention group

Description:

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

Household prophylaxis

Active Comparator group

Description:

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).

Treatment:

Drug: Ciprofloxacin

Village prophylaxis

Active Comparator group

Description:

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).

Treatment:

Drug: Ciprofloxacin