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.

Ciprofloxacin for the Prevention of Meningococcal Meningitis

Meningitis, Meningococcal

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.

Ciprofloxacin

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

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.

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

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).

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).

Ciprofloxacin for the Prevention of Meningococcal Meningitis

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status