Comorbidities and Coinfections in Latent TB

Launched by TUBERCULOSIS RESEARCH CENTRE, INDIA · Nov 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how certain health conditions, like diabetes, malnutrition, and infections from worms (helminths), affect people who have latent tuberculosis (LTBI). LTBI means that a person is infected with the bacteria that cause tuberculosis, but they do not have active disease and do not show symptoms. Researchers want to find out how common these health issues are among people with LTBI and see if they increase the risk of developing active TB disease.

To participate in this study, individuals aged 14 to 65 who are willing to provide samples of blood, urine, and stool can apply. Participants will be grouped based on their health status: some will have LTBI along with diabetes, malnutrition, or helminth infections, while others will be healthy individuals who do not have these conditions. Over the course of up to 6 months, participants can expect to undergo various tests and assessments to help researchers better understand the link between these health issues and TB. It’s important for potential participants to know that they will be screened to ensure they do not have symptoms of active TB or other serious health conditions before joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Screening Phase:
• Individuals who meet the following criteria are eligible to participate in the screening phase:
• • 1. Aged 14 to 65 years.
• • 2. Willingness to provide blood, urine, and stool samples for examination.
• • 3. Willingness to have samples and data stored.
• • 4. Able to provide informed consent.
• Study Phase:
• Individuals are eligible for the study phase if they meet the requirements for one of the study groups, as follows:
• • 1. LTBI+ and severe to moderate malnutrition (BMI \<17 kg/m2);
• • 2. LTBI+ and uncontrolled DM (HbA1c \>8%);
• • 3. LTBI+ and helminth infection (positive stool qPCR and/or serology);
• • 4. LTBI+ with more than one of the conditions defined in groups 1-3;
• • 5. "healthy" LTBI+ controls who are negative for all of the above conditions; and
• • 6. healthy LTBI negative controls with none of the above conditions.
• Exclusion Criteria:
• Screening Phase:
• • 1. Pulmonary symptoms suggestive of TB (cough \>2 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis).
• • 2. Two IGRA tests with indeterminate results (mitogen values \<10 IU).
• Study Phase:
• • 1. Pulmonary symptoms suggestive of TB (cough \>2 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis).
• • 2. Pregnant or lactating women.
• • 3. Previous treatment for LTBI.
• • 4. Anemia with hemoglobin \<8 g/dl (evaluated at the screening phase visit).
• • 5. For LTBI+ participants, clinically indicated chest X-ray positive for pulmonary TB.
• • 6. For malnourished participants, clinically indicated abdominal ultrasound positive for abdominal TB.
• • 7. Known documented cases of cancer, acquired immune deficiency syndrome, or other immunosuppressive illness.
• • 8. History of any other illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the participant's participation in the protocol, or compromise the scientific objectives.