Ciprofloxacin for the Prevention of Meningococcal Meningitis

NCT02724046 | Completed Phase 4

• 1 other identifier: Ciprofloxacin chemoprophylaxis
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningitis, Meningococcal

Keywords

Neisseria meningitidis; Ciprofloxacin; Chemoprevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of participants with ciprofloxacin-resistant enterobacteriaceae in their stools

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

• Proportion of patients who received ciprofloxacin who develop meningitis

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

Study Arms (3)

Standard care

NO INTERVENTION

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

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).

Drug: Ciprofloxacin

Village prophylaxis

ACTIVE COMPARATOR

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).

Drug: Ciprofloxacin

Interventions

Ciprofloxacin DRUG

Single-dose oral ciprofloxacin

Also known as: Cipro

Household prophylaxis; Village prophylaxis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident in a village included in the study area

You may not qualify if:

• Patients currently exhibiting symptoms of meningitis (to be immediately referred for further care)
• Persons with a known allergy to fluoroquinolone antibiotics.

Sponsors & Collaborators

• Epicentre: lead
• Medecins Sans Frontieres, Netherlands: collaborator

Study Sites (1)

Madarounfa Health District

Madarounfa, Maradi Region, Niger

Location

Related Publications (2)

• 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.

  PMID: 29944651 DERIVED

• 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.

  PMID: 28646924 DERIVED

MeSH Terms

Conditions

Meningitis, Meningococcal

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rebecca F Grais, PhD

  Epicentre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 31, 2016
• Study Start: April 22, 2017
• Primary Completion: May 30, 2017
• Study Completion: June 12, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

NI (1)