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Completed

NCT Number: NCT02724046

Ciprofloxacin for the Prevention of Meningococcal Meningitis

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.

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Key information

Conditions

Meningitis, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Meningitis Meningitis, Bacterial Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Madarounfa Health District

Madarounfa, Maradi Region, Niger

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciprofloxacin

Drug

Single-dose oral ciprofloxacin

Other names: Cipro

Primary outcomes

  1. Meningitis Attack Rate

    Time frame: From enrollment of a village through study completion, an average of 3 months

    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.

Secondary outcomes

  1. Proportion of participants with ciprofloxacin-resistant enterobacteriaceae in their stools

    Time frame: Prior to ciprofloxacin dosing (day 0) and at 7 days and 28 days post-ciprofloxacin dosing

    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

  2. Proportion of patients who received ciprofloxacin who develop meningitis

    Time frame: From enrollment of a village through study completion, an average of 3 months

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

  • Medecins Sans Frontieres, Netherlands

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2016
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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