Meningitis, MeningococcalPhase 4NCT02724046
Ciprofloxacin for the Prevention of Meningococcal Meningitis
A Phase 4 study testing Ciprofloxacin in people with Meningitis, Meningococcal, run by Epicentre at 1 site in Niger.
Trial summary
This study evaluates the effect of antibiotic prophylaxis with ciprofloxacin, given to the contacts of meningitis cases, on the overall attack rate 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
- 300 participants
- Where
- 1 siteNiger
- Study dates
- 22 Apr 2017to 12 Jun 2017
- 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 for Contacts of Cases of Meningococcal Meningitis as an Epidemic Response
This study evaluates the effect of antibiotic prophylaxis with ciprofloxacin, given to the contacts of meningitis cases, on the overall attack rate of meningitis during an epidemic. One third of enrolled villages will receive standard care; in one-third of villages, household contacts of meningitis cases will be offered a single dose of oral ciprofloxacin; and in one-third of villages, the entire village will be offered a single dose of oral ciprofloxacin after the notification of the first case in the village.
Read the detailed description
Antibiotic prophylaxis is not currently recommended for contacts of cases during a meningitis epidemic in the African Meningitis Belt. Reactive vaccination campaigns are the preferred strategy for prevention during an epidemic.
A novel strain of meningococcus, Neisseria meningitidis serogroup C (NmC), began circulating in Nigeria in 2013 and caused a major epidemic with over 10 000 cases in Nigeria and Niger in 2015.
There is currently a global shortage of vaccine against NmC, and a recent WHO expert panel called for the formal evaluation of antibiotic prophylaxis as another epidemic response strategy.
When taken as a single dose, oral ciprofloxacin effectively eliminates nasopharyngeal carriage of meningococcus.
This trial aims to investigate two different antibiotic prophylaxis strategies during an epidemic of meningococcal meningitis: ciprofloxacin prophylaxis to household members of cases and village-wide prophylaxis after the notification of a case in a village. These two strategies will be compared to villages receiving standard care.
- Conditions
- Meningitis, Meningococcal
- Being tested
- Ciprofloxacin
- Keywords
- Neisseria meningitidis, Ciprofloxacin, Chemoprevention
- 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 | 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 |
| Village prophylaxis | 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 3 months
Secondary outcomes (2)
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 days and 28 days post-ciprofloxacin dosing
Proportion of patients who received ciprofloxacin who develop meningitis
Measured: From enrollment of a village through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study start22 Apr 2017
- Primary completion30 May 2017
- Study completion12 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 300 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
- NCT02724046
- Sponsor's protocol ID
- Ciprofloxacin chemoprophylaxis
- Status last verified
- Feb 2018
- First submitted
- 15 Mar 2016
- Last updated
- 8 Feb 2018
- 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.
Publications
Coldiron ME, Assao B, Page AL, Hitchings MDT, Alcoba G, Ciglenecki I, Langendorf C, Mambula C, Adehossi E, Sidikou F, Tassiou EI, De Lastours V, Grais RF. Single-dose oral ciprofloxacin prophylaxis as a response to a meningococcal meningitis epidemic in the African meningitis belt: A 3-arm, open-label, cluster-randomized trial. PLoS Med. 2018 Jun 26;15(6):e1002593. doi: 10.1371/journal.pmed.1002593. eCollection 2018 Jun.
PubMed 29944651Coldiron ME, Alcoba G, Ciglenecki I, Hitchings M, Djibo A, Page AL, Langendorf C, Grais RF. Ciprofloxacin for contacts of cases of meningococcal meningitis as an epidemic response: study protocol for a cluster-randomized trial. Trials. 2017 Jun 24;18(1):294. doi: 10.1186/s13063-017-2028-y.
PubMed 28646924
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster-randomized Trial to Evaluate the Impact of Ciprofloxacin for Contacts of Cases of Meningococcal Meningitis as an Epidemic Response
- ClinicalTrials.gov ID
- NCT02724046
- Acronym / sponsor ID
- Ciprofloxacin chemoprophylaxis
- Conditions
- Meningitis, Meningococcal
- Keywords
- Neisseria meningitidis, Ciprofloxacin, Chemoprevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Study start
- 22 Apr 2017 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 12 Jun 2017 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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.
This study evaluates the effect of antibiotic prophylaxis with ciprofloxacin, given to the contacts of meningitis cases, on the overall attack rate of meningitis during an epidemic. One third of enrolled villages will receive standard care; in one-third of villages, household contacts of meningitis cases will be offered a single dose of oral ciprofloxacin; and in one-third of villages, the entire village will be offered a single dose of oral ciprofloxacin after the notification of the first case in the village.
Detailed description
Antibiotic prophylaxis is not currently recommended for contacts of cases during a meningitis epidemic in the African Meningitis Belt. Reactive vaccination campaigns are the preferred strategy for prevention during an epidemic.
A novel strain of meningococcus, Neisseria meningitidis serogroup C (NmC), began circulating in Nigeria in 2013 and caused a major epidemic with over 10 000 cases in Nigeria and Niger in 2015.
There is currently a global shortage of vaccine against NmC, and a recent WHO expert panel called for the formal evaluation of antibiotic prophylaxis as another epidemic response strategy.
When taken as a single dose, oral ciprofloxacin effectively eliminates nasopharyngeal carriage of meningococcus.
This trial aims to investigate two different antibiotic prophylaxis strategies during an epidemic of meningococcal meningitis: ciprofloxacin prophylaxis to household members of cases and village-wide prophylaxis after the notification of a case in a village. These two strategies will be compared to villages receiving standard care.
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 | 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). |
| Village prophylaxis | 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 | Household prophylaxis, Village prophylaxis |
Primary outcome
Meningitis Attack Rate
Time frame: From enrollment of a village through study completion, an average of 3 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.
2 secondary outcomes
Proportion of participants with ciprofloxacin-resistant enterobacteriaceae in their stools
Time frame: Prior to ciprofloxacin dosing (day 0) and at 7 days 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 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Derived from this study: PubMed 29944651Coldiron ME, Assao B, Page AL, Hitchings MDT, Alcoba G, Ciglenecki I, Langendorf C, Mambula C, Adehossi E, Sidikou F, Tassiou EI, De Lastours V, Grais RF. Single-dose oral ciprofloxacin prophylaxis as a response to a meningococcal meningitis epidemic in the African meningitis belt: A 3-arm, open-label, cluster-randomized trial. PLoS Med. 2018 Jun 26;15(6):e1002593. doi: 10.1371/journal.pmed.1002593. eCollection 2018 Jun.
- Derived from this study: PubMed 28646924Coldiron ME, Alcoba G, Ciglenecki I, Hitchings M, Djibo A, Page AL, Langendorf C, Grais RF. Ciprofloxacin for contacts of cases of meningococcal meningitis as an epidemic response: study protocol for a cluster-randomized trial. Trials. 2017 Jun 24;18(1):294. doi: 10.1186/s13063-017-2028-y.
- 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: finished, as of the sponsor's last update on 8 Feb 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724046, which also lists 2 linked publications.
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 8 Feb 2018.