Meningitis, Meningococcal Clinical Trial
Official title:
Cluster-randomized Trial to Evaluate the Impact of Ciprofloxacin Prophylaxis as a Response to a Meningococcal Meningitis Epidemic
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.
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.
;
| 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 |