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

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ClinicalTrials.gov Identifier: NCT04547738
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel Ritter, University Hospital, Bonn

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?

Condition or disease Intervention/treatment
Tuberculosis Drug: TB treatment according to national guidelines

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mansonella Perstans Effects on BCG Vaccine-induced Protection Against Childhood Tuberculosis (TB) as Well as TB Disease Severity and Recovery in Cameroon (MAP-TB)
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
Tuberculosis (TB) index patients
- Patients (older than 5 years) diagnosed with TB before initiation of TB treatment
Drug: TB treatment according to national guidelines
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
Drug: TB treatment according to national guidelines
National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis




Primary Outcome Measures :
  1. Influence of filariae infection on TB disease outcome and BCG vaccination [ Time Frame: 3 years ]

    Does filarial infection influence tuberculosis disease severity and recovery under treatment and influence Bacille Calmette-Guérin (BCG)-induced protection against disease progression

    Parasitological diagnosis:

    • Blood smear for microfilaria detection using microscopy
    • DNA isolation from urine, blood and stool for helminth detection using LAMP and PCR technology
    • Helminth egg detection in urine and stool using Kato Katz technique
    • Skin snip for detection of Onchocerca volvulus infection

    TB diagnosis:

    • Chest radiography
    • Sputum smear and culture
    • GeneXpert
    • TST Test
    • Physical examination
    • Questionnaires to obtain medical, TB contact and treatment history


Secondary Outcome Measures :
  1. Biomarkers for TB severity and BCG vaccination [ Time Frame: 3 years ]

    Decipher biomarker for TB disease severity and recovery under treatment and for prediction of BCG vaccine induced immune protection against development of TB

    Laboratory assessment:

    - CFP10/ESAT6 in vitro and TB-TAM assay from peripheral whole blood using flow cytometry technology




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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • TB positive individuals (older than 5 years)
  • TB contacts (children 5-17 years old)
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

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): NCT04547738


Contacts
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Contact: Samuel Wanji, Prof. Dr. +237 77 72 43 84 swanji@yahoo.fr
Contact: Manuel Ritter, Dr. +4928828711453 manuel.ritter@ukbonn.de

Locations
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Cameroon
University of Buea Recruiting
Buea, Cameroon
Contact: Samuel Wanji    +237694727715    samwandji@gmail.com   
Sponsors and Collaborators
University Hospital, Bonn
Investigators
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Principal Investigator: Achim Hoerauf, Prof. Dr. UKB, IMMIP
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Responsible Party: Manuel Ritter, Prinicpal investigator, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT04547738    
Other Study ID Numbers: HO2009/14-1
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Manuel Ritter, University Hospital, Bonn:
filariae
tuberculosis
BCG vaccination
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections