Meningitis, MeningococcalPhase 4NCT03431675
Ciprofloxacin for the Prevention of Meningococcal Meningitis 2018
A Phase 4 study testing Ciprofloxacin in people with Meningitis, Meningococcal, run by Epicentre at 1 site in Niger.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNiger
- Study dates
- 1 Mar 2019to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resident in a village included in the study area
Who cannot join
- Patients currently exhibiting symptoms of meningitis (to be immediately referred for further care)
- Persons with a known allergy to fluoroquinolone antibiotics.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Meningitis, Meningococcal
- Being tested
- Ciprofloxacin
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Also called Cipro
Single-dose oral ciprofloxacin
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: Prior to ciprofloxacin dosing (day 0) and at 7 and 28 days post-ciprofloxacin dosing
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.
Measured: From enrollment of a village through study completion, an average of 2 months
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.
Measured: From enrollment of a village through study completion, an average of 2 months
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.
Measured: From enrollment of a village through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Mar 2019 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: No epidemic of Men C in 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningitis, MeningococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Responsible party
- Sponsor
- Investigators
- Rebecca F GRAIS, PhD, Study director, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431675
- Sponsor's protocol ID
- Cipro chemoprophylaxis 2018
- Status last verified
- Aug 2019
- First submitted
- 6 Feb 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified data set can be made available after the signature of an appropriate data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster-randomized Trial to Evaluate the Impact of Ciprofloxacin Prophylaxis as a Response to a Meningococcal Meningitis Epidemic
- ClinicalTrials.gov ID
- NCT03431675
- Acronym / sponsor ID
- Cipro chemoprophylaxis 2018
- Conditions
- Meningitis, Meningococcal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No epidemic of Men C in 2019
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: CiprofloxacinChemoprophylaxis 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) |
| Community prophylaxis arm | Active comparator | Drug: CiprofloxacinChemoprophylaxis 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resident in a village included in the study area
Key exclusion criteria (2 listed)
- Patients currently exhibiting symptoms of meningitis (to be immediately referred for further care)
- Persons with a known allergy to fluoroquinolone antibiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofloxacinAlso: CiproSingle-dose oral ciprofloxacin | Drug | Community prophylaxis arm, Household prophylaxis arm |
Primary outcome
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.
4 secondary outcomes
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
Proportion of patients who received ciprofloxacin who develop meningitis
Time frame: From enrollment of a village through study completion, an average of 2 months
Meningitis attack rate by sex
Time frame: From enrollment of a village through study completion, an average of 2 months
Meningitis attack rate by age
Time frame: From enrollment of a village through study completion, an average of 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: Yes. A de-identified data set can be made available after the signature of an appropriate data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca F GRAIS, PhD study director
Epicentre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofloxacin in people with Meningitis, Meningococcal, run by Epicentre at 1 site in Niger.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Niger. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meningitis attack rate (time frame: From enrollment of a village through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.