Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03431675
Other study ID # Cipro chemoprophylaxis 2018
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date March 1, 2019
Est. completion date December 31, 2019

Study information

Verified date August 2019
Source Epicentre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2019
Est. primary completion date June 30, 2019
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.

Study Design


Related Conditions & MeSH terms


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 2 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 and 28 days post-ciprofloxacin dosing
Secondary Proportion of patients who received ciprofloxacin who develop meningitis 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. From enrollment of a village through study completion, an average of 2 months
Secondary Meningitis attack rate by sex 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. From enrollment of a village through study completion, an average of 2 months
Secondary Meningitis attack rate by age 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. From enrollment of a village through study completion, an average of 2 months
See also
  Status Clinical Trial Phase
Recruiting NCT04689191 - A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine Phase 3
Recruiting NCT04689165 - A Phase III Clinical Trial of the Group A Meningococcal Polysaccharide Vaccine Phase 3
Completed NCT00780806 - Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults Phase 1/Phase 2
Completed NCT03378258 - Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.
Completed NCT03205371 - Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers Phase 3
Completed NCT01352793 - A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years Phase 3
Not yet recruiting NCT06113198 - A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age Phase 4
Completed NCT03295318 - Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds Phase 2
Completed NCT03493919 - A Sourcing Study to Collect Human Blood Samples From Healthy Adults Phase 4
Completed NCT00474526 - A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants Phase 3
Completed NCT00297687 - Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults Phase 1
Recruiting NCT04665791 - A Human Controlled Infection Study With Neisseria Lactamica in Malian Adults N/A
Recruiting NCT02878291 - Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months Phase 1
Completed NCT00314041 - Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants Phase 2
Recruiting NCT04685850 - Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans
Completed NCT03587207 - Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years Phase 2
Completed NCT03824093 - High and Low Resource Interventions to Promote HPV Vaccines N/A
Completed NCT04707391 - Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine Phase 3
Terminated NCT00798304 - Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants Phase 2
Recruiting NCT03682939 - Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population Phase 4