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Ciprofloxacin for the Prevention of Meningococcal Meningitis 2018

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431675
Recruitment Status : Withdrawn (No epidemic of Men C in 2019)
First Posted : February 13, 2018
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Medecins Sans Frontieres, Netherlands
Information provided by (Responsible Party):
Epicentre

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE February 13, 2018
Last Update Posted Date August 14, 2019
Estimated Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
Meningitis attack rate [ Time Frame: From enrollment of a village through study completion, an average of 2 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
  • Proportion of participants with ciprofloxacin-resistant enterobacteriaceae in their stools [ Time Frame: Prior to ciprofloxacin dosing (day 0) and at 7 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
  • Proportion of patients who received ciprofloxacin who develop meningitis [ Time Frame: From enrollment of a village through study completion, an average of 2 months ]
    This secondary 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.
  • Meningitis attack rate by sex [ Time Frame: From enrollment of a village through study completion, an average of 2 months ]
    This secondary 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.
  • Meningitis attack rate by age [ Time Frame: From enrollment of a village through study completion, an average of 2 months ]
    This secondary 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ciprofloxacin for the Prevention of Meningococcal Meningitis 2018
Official Title  ICMJE Cluster-randomized Trial to Evaluate the Impact of Ciprofloxacin Prophylaxis as a Response to a Meningococcal Meningitis Epidemic
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.

Detailed Description

The study is designed as a cluster-randomized trial in the setting of a meningitis epidemic to assess the impact of chemoprophylaxis with single-dose ciprofloxacin on the incidence of meningitis in the study area.

The study will be implemented in a health district in Niger where a meningitis outbreak is occurring, and where Médecins Sans Frontières is providing assistance to the Ministry of Health in its outbreak response. In order to launch the study protocol, at least two Health Areas (HA) of a Health District (HD) will have met the weekly epidemic threshold of 10 cases per 100 000 per week, or of 5 cases per week if the population of the HA is less than 30 000 people, following the most recent WHO recommendations for meningitis surveillance.

All villages in the HAs which have crossed the epidemic threshold and are included in the study area will be randomized to receive standard care, household-level prophylaxis or community-wide prophylaxis.

Once a HA has been included in the study, a case-based surveillance system will be put in place, or reinforced if one is currently in place in the study area. Suspected cases of meningitis that present to health posts will be referred to the nearest health center. In each health center, the diagnosis and treatment of meningitis will follow national protocols.

In the standard care arm, after the first case has been notified from a village, a study nurse will visit the village with a local community member. The study nurse will lead an informational session for members of the community regarding the signs and symptoms of meningitis, and the urgency of presenting to the nearest health center as soon as possible if any of those signs or symptoms arrive. In the household-level prophylaxis arm, each time a case is reported from a village that has been randomized to this arm, a study nurse will visit the household of the notified case within 24 hours. The study nurse will offer ciprofloxacin to all persons currently living in the same household compound and present at the time of the visit. In the community-level prophylaxis arm, after the first case is reported from a village that has been randomized to this arm, a member of study staff will visit the village within 24 hours. During this visit, arrangements will be made for a community-wide distribution of ciprofloxacin, preferably within 72 hours of the initial case presentation at the health center / district hospital. A series of informational meetings will be organized before the distribution.

If the epidemic is in an urban setting, neighborhoods will be randomized to one of the three arms in a 1:1:1 ratio. If the epidemic is in a rural area, villages will be randomized to either standard care or village-wide prophylaxis in a 1:1 ratio.

A nested substudy to assess the effects of ciprofloxacin prophylaxis on the prevalence of ciprofloxacin-resistant enterobacteriaceae will be carried out among 400 persons (200 in the standard care arm and 200 in the community-wide prophylaxis arm). Participants will provide a series of 3 stool samples for culture, speciation, and antibiotic resistance testing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningitis, Meningococcal
Intervention  ICMJE Drug: Ciprofloxacin
Single-dose oral ciprofloxacin
Other Name: Cipro
Study Arms  ICMJE
  • No Intervention: Standard care
    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
  • Active Comparator: Household prophylaxis arm
    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)
    Intervention: Drug: Ciprofloxacin
  • Active Comparator: Community prophylaxis arm
    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)
    Intervention: Drug: Ciprofloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 13, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2018)
300
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Niger
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03431675
Other Study ID Numbers  ICMJE Cipro chemoprophylaxis 2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: A de-identified data set can be made available after the signature of an appropriate data sharing agreement.
Responsible Party Epicentre
Study Sponsor  ICMJE Epicentre
Collaborators  ICMJE Medecins Sans Frontieres, Netherlands
Investigators  ICMJE
Study Director: Rebecca F GRAIS, PhD Epicentre
PRS Account Epicentre
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP