Ciprofloxacin for the Prevention of Meningococcal Meningitis 2018

NCT03431675 | Withdrawn Phase 4

• 1 other identifier: Cipro chemoprophylaxis 2018
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is an interventional, cluster-randomized trial to assess the impact of oral ciprofloxacin for household and community contacts of meningitis cases on the incidence of meningitis during an epidemic. The trial contains a nested sub-study ("resistance study") to assess the effect of a single dose of ciprofloxacin on the prevalence of fluoroquinolone-resistant enterobacteriaceae in the study area.

Conditions

Meningitis, Meningococcal

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 2 months

Secondary Outcomes (4)

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

  Prior to ciprofloxacin dosing (day 0) and at 7 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 2 months

• Meningitis attack rate by sex

  From enrollment of a village through study completion, an average of 2 months

• Meningitis attack rate by age

  From enrollment of a village through study completion, an average of 2 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 arm

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

Community prophylaxis arm

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

Community prophylaxis arm; Household prophylaxis arm

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

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: February 6, 2018
• First Posted: February 13, 2018
• Study Start: March 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

NI (1)