Ciprofloxacin for the Prevention of Meningococcal Meningitis

Meningitis, Meningococcal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724046
• Other study ID #: Ciprofloxacin chemoprophylaxis
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2016
• Last updated: February 6, 2018
• Start date: April 22, 2017
• Est. completion date: June 12, 2017

Study information

• Verified date: February 2018
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 12, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal

Intervention

Drug:
• Ciprofloxacin
Single-dose oral ciprofloxacin

Locations

Country	Name	City	State
Niger	Madarounfa Health District	Madarounfa	Maradi

Sponsors (2)

Lead Sponsor	Collaborator
Epicentre	Medecins Sans Frontieres, Netherlands

Country where clinical trial is conducted

Niger, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From enrollment of a village through study completion, an average of 3 months
Secondary	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	Prior to ciprofloxacin dosing (day 0) and at 7 days and 28 days post-ciprofloxacin dosing
Secondary	Proportion of patients who received ciprofloxacin who develop meningitis		From enrollment of a village through study completion, an average of 3 months