A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

Launched by SPP PHARMACLON LTD. · Nov 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Ingaron to see how effective and safe it is for patients with pulmonary tuberculosis, a serious lung infection. The trial is currently looking for participants who are between 18 and 78 years old, have been diagnosed with tuberculosis, and are receiving intensive treatment for their condition. To take part, individuals must agree to stay in the hospital for their tuberculosis therapy until the study is complete.

Participants in this trial can expect to be monitored closely while receiving treatment with Ingaron. However, not everyone can join. People with serious health issues, those who are pregnant or breastfeeding, and patients who have had certain allergic reactions to Ingaron or who have severe liver or kidney problems will not be eligible. This trial aims to find out if Ingaron can help improve treatment for those battling tuberculosis, and your participation could contribute to important research in this area.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age from 18 to 78 years inclusive
• • 2. Bacterioscopically and/or molecularly genetically verified diagnosis of tuberculosis
• • 3. Stay in the intensive phase of treatment
• • 4. Consent to inpatient anti-tuberculosis therapy until the end of participation in clinical observation
• Exclusion Criteria:
• • 1. Serious condition
• • 2. Pregnancy
• • 3. Breastfeeding
• • 4. Treatment with immunomodulatory drugs before inclusion in the observation program
• • 5. Presence of medical history of an allergic reaction or individual intolerance to the drug Ingaron
• • 6. Severe diseases of the liver, kidneys (creatinine more than 150 mmol/l)
• • 7. Presence of contraindications to the administration of the drug Ingaron
• • 8. Patients with HIV infection with a CD4 lymphocyte count less than 350 cells/ml