UnknownNot Applicable

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

Cameroon2,500 participantsStarted 2020-12-01

Plain-language 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?

Who can participate

Age range

5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Influence of filariae infection on TB disease outcome and BCG vaccination

Timeframe: 3 years

Trial details

NCT IDNCT04547738

SponsorUniversity Hospital, Bonn

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-01

Contact for this trial

Samuel Wanji, Prof. Dr.

+237 77 72 43 84 swanji@yahoo.fr

View on ClinicalTrials.gov More Tuberculosis trials