Influence of Filarial Infections on Tuberculosis Disease and Tuberculosis Vaccination in Cameroon

NCT ID: NCT04547738

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-10-01

Brief Summary

Filarial nematodes modulate the host immune response to promote regulatory and T helper type 2 immune responses, which were shown to influence concomitant infections. Indeed, several studies showed that increased susceptibility and worsened disease course of HIV, tuberculosis (TB) and malaria in filarial endemic regions. Moreover, the investigators demonstrated that M. perstans infections polarize and suppress immune responses with likely consequences for concomitant infections and vaccine-induced protection. In addition, the investigators observed altered frequencies of natural killer and regulatory T and B cells in filarial and M. tuberculosis co-infected individuals and that M. perstans influences CD4+ T cell function and immune responses upon purified protein derivative antigen stimulation. Nevertheless, the consequences of manifestation of TB disease and influence on TB vaccination remains unknown. Thus, the trial aim to address two main questions with high clinical relevance: 1) Does filarial infection influence disease severity and recovery in tuberculosis patients? 2) Does filarial infection influence Bacille Calmette-Guérin (BCG)-induced protection against disease progression in vaccinated children?

Conditions

Tuberculosis

Keywords

filariae; tuberculosis; BCG vaccination

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tuberculosis (TB) index patients

\- Patients (older than 5 years) diagnosed with TB before initiation of TB treatment

TB treatment according to national guidelines

Intervention Type: DRUG

National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis

TB contacts

\- Children (5-17 years old), who had contact with TB index patients

TB treatment according to national guidelines

Intervention Type: DRUG

National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis

Interventions

TB treatment according to national guidelines

National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient is older than 5 years old
• Patient have BCG scare or get the BCG vaccination at birth
• Patient had no previous treatment of, tuberculosis or with at least one of the study drugs i.e. isoniazid,rifampicin, pyraziamide, ethambutol
• Patient have no history of hypersensitivity to rifampicin, or any of the above mentioned drugs
• Patient is not on any medication likely to interact with the study medication
• Patient have no history of or current clinical signs of ascites, jaundice, partial or complete deafness, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and severe immune compromise (e.g., immunosuppressive drugs after organ transplant), or have no evidence of (previous) tuberculosis, Buruli ulcer or leprosy and no terminal illness (e.g., metastasized cancer)
• Patient have no mental condition
• Patient is able to take oral medication
• Patient have no mental condition including addiction with substance abuse e.g. alcohol
• Patient is willing to give informed pre-consent, and consent
• In case the patient is below 18, the parents or legal guardians were informed and provide consent

Exclusion Criteria

• Patient is younger than 5 years old
• Patient have no BCG scare or miss the BCG vaccination at birth
• Patient had previous treatment of, tuberculosis or with at least one of the study drugs i.e. isoniazid,rifampicin, pyraziamide, ethambutol
• Patient have a history of hypersensitivity to rifampicin, or any of the above mentioned drugs
• Patient is on any medication likely to interact with the study medication
• Patient have a history of or current clinical signs of ascites, jaundice, partial or complete deafness, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and severe immune compromise (e.g., immunosuppressive drugs after organ transplant), or evidence of (previous) tuberculosis, Buruli ulcer or leprosy; or terminal illness (e.g., metastasized cancer)
• Patient have a mental condition including addiction with substance abuse e.g. alcohol likely to interfere with possibility to comply with study protocol
• Patient is unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption
• Patient have a mental condition including addiction with substance abuse e.g. alcohol likely to interfere with possibility to comply with study protocol
• Patient is not willing to give informed pre-consent, and consent or withdrawal or consent
• In case the patient is below 18, were the parents or legal guardians were not informed and did not provide consent

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Manuel Ritter

Prinicpal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Achim Hoerauf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

UKB, IMMIP

Locations

University of Buea

Buea, , Cameroon

Site Status: RECRUITING

Countries

Cameroon

Central Contacts

Samuel Wanji, Prof. Dr.

Role: CONTACT

Phone: +237 77 72 43 84

Email: swanji@yahoo.fr

Manuel Ritter, Dr.

Role: CONTACT

Phone: +4928828711453

Email: manuel.ritter@ukbonn.de

Facility Contacts

Samuel Wanji

Role: primary

Other Identifiers

HO2009/14-1

Identifier Type: -

Identifier Source: org_study_id