Mansonella Perstans Effects on BCG Vaccine-induced Protection Against Childhood Tuberculosis (TB) as Well as TB Disease Severity and Recovery in Cameroon (MAP-TB)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Influence of filariae infection on TB disease outcome and BCG vaccination
研究概览
简要总结
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?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tuberculosis (TB) index patients
- Patients (older than 5 years) diagnosed with TB before initiation of TB treatment
干预措施: TB treatment according to national guidelines (Drug)
TB contacts
- Children (5-17 years old), who had contact with TB index patients
干预措施: TB treatment according to national guidelines (Drug)
结局指标
主要结局
Influence of filariae infection on TB disease outcome and BCG vaccination
时间窗: 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
次要结局
- Biomarkers for TB severity and BCG vaccination(3 years)
研究者
Manuel Ritter
Prinicpal investigator
University Hospital, Bonn