TuberculosisMAP-TBNCT04547738
Influence of Filarial Infections on Tuberculosis Disease and Tuberculosis Vaccination in Cameroon
An observational study of Tuberculosis, run by University Hospital, Bonn at 1 site in Cameroon.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- TB treatment according to national guidelines
- How many people
- 2,500 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Dec 2020to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * TB positive individuals (older than 5 years) * TB contacts (children 5-17 years old)
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Cameroon1 site, 1 recruiting
- Recruiting
University of Buea
Buea
Samuel Wanji, +237694727715, samwandji@gmail.com
About this study
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)
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
- Being tested
- TB treatment according to national guidelines
- Keywords
- filariae, tuberculosis, BCG vaccination
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB treatment according to national guidelinesDrug
National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Tuberculosis (TB) index patients | - Patients (older than 5 years) diagnosed with TB before initiation of TB treatment Receives: Drug: TB treatment according to national guidelines | |
| TB contacts | - Children (5-17 years old), who had contact with TB index patients Receives: Drug: TB treatment according to national guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of filariae infection on TB disease outcome and BCG vaccination
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
Measured: 3 years
Secondary outcomes (1)
Biomarkers for TB severity and BCG vaccination
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Dec 2020
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Ritter, University Hospital, Bonn
- Investigators
- Achim Hoerauf, Prof. Dr., Principal investigator, UKB, IMMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547738
- Sponsor's protocol ID
- HO2009/14-1
- Acronym
- MAP-TB
- Status last verified
- Nov 2021
- First submitted
- 4 Sep 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04547738
- Acronym / sponsor ID
- MAP-TB / HO2009/14-1
- Conditions
- Tuberculosis
- Keywords
- filariae, tuberculosis, BCG vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tuberculosis (TB) index patients | – | Drug: TB treatment according to national guidelines- Patients (older than 5 years) diagnosed with TB before initiation of TB treatment |
| TB contacts | – | Drug: TB treatment according to national guidelines- Children (5-17 years old), who had contact with TB index patients |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * TB positive individuals (older than 5 years) * TB contacts (children 5-17 years old)
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB treatment according to national guidelinesNational clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis | Drug | TB contacts, Tuberculosis (TB) index patients |
Primary outcome
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
1 secondary outcome
Biomarkers for TB severity and BCG vaccination
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achim Hoerauf, Prof. Dr. principal investigator
UKB, IMMIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by University Hospital, Bonn at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Wanji, Prof. Dr. (+237 77 72 43 84, swanji@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of filariae infection on TB disease outcome and BCG vaccination (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.