Influence of Filarial Infections on Tuberculosis Disease and Tuberculosis Vaccination in Cameroon (MAP-TB)

University Hospital Bonn (UKB)

Status

Unknown

Conditions

Tuberculosis

Treatments

Drug: TB treatment according to national guidelines

Study type

Observational

Funder types

Other

Identifiers

NCT04547738

HO2009/14-1

Details and patient eligibility

About

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?

Enrollment

2,500 estimated patients

Sex

All

Ages

5+ years old

Volunteers

Accepts Healthy Volunteers

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