Ciprofloxacin for the Prevention of Meningococcal Meningitis

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ClinicalTrials.gov Identifier: NCT02724046

Recruitment Status : Completed

First Posted : March 31, 2016

Last Update Posted : February 8, 2018

Sponsor:

Collaborator:

Medecins Sans Frontieres, Netherlands

Information provided by (Responsible Party):

Epicentre

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Meningitis, Meningococcal	Drug: Ciprofloxacin	Phase 4

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Cluster-randomized Trial to Evaluate the Impact of Ciprofloxacin for Contacts of Cases of Meningococcal Meningitis as an Epidemic Response
Actual Study Start Date :	April 22, 2017
Actual Primary Completion Date :	May 30, 2017
Actual Study Completion Date :	June 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride

Genetic and Rare Diseases Information Center resources: Bacterial Meningitis Meningococcal Infection

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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 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).	Drug: Ciprofloxacin Single-dose oral ciprofloxacin Other Name: Cipro
Active Comparator: Village prophylaxis 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).	Drug: Ciprofloxacin Single-dose oral ciprofloxacin Other Name: Cipro

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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 ]
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 3 months ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724046

Locations

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Niger
Madarounfa Health District
Madarounfa, Maradi, Niger

Sponsors and Collaborators

Epicentre

Medecins Sans Frontieres, Netherlands

Investigators

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Study Director:	Rebecca F Grais, PhD	Epicentre

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Coldiron 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.

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Responsible Party:	Epicentre
ClinicalTrials.gov Identifier:	NCT02724046
Other Study ID Numbers:	Ciprofloxacin chemoprophylaxis
First Posted:	March 31, 2016 Key Record Dates
Last Update Posted:	February 8, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Epicentre:


Neisseria meningitidis Ciprofloxacin Chemoprevention

Additional relevant MeSH terms:

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Meningitis, Meningococcal Meningitis Central Nervous System Diseases Nervous System Diseases Meningitis, Bacterial Central Nervous System Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections	Central Nervous System Infections Ciprofloxacin Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors

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