Early Empiric Anti-Mycobacterium Tuberculosis Therapy for Sepsis in Sub-Saharan Africa

Launched by UNIVERSITY OF VIRGINIA · Nov 4, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how early treatment with anti-tuberculosis (TB) medication can help patients with sepsis who are also living with HIV in sub-Saharan Africa. Sepsis is a severe infection that can be life-threatening, and in this region, TB is a common cause of sepsis. The researchers want to find out if starting TB treatment right away, along with standard hospital care, will improve survival rates over the first 28 days for these patients. The trial is taking place in Uganda and Tanzania, and it will also compare different doses of the TB medication to see which is most effective.

To participate in the study, individuals must be at least 18 years old, living with HIV, and admitted to the hospital with signs of infection and a specific set of symptoms indicating sepsis. They should also be able to commit to the study requirements for its duration. However, those who are pregnant, currently receiving TB treatment, or have certain health conditions will not be eligible. Participants can expect to receive regular medical care while being closely monitored throughout the trial. This study aims to improve treatment options for a serious condition that affects many people in this region.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of signed and dated informed consent form
• • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
• • 3. Male or female aged ≥18 years living with HIV
• • 4. Admitted to hospital with 1) clinical concern for infection; 2) ≥2 qSOFA score criteria (Glasgow Coma Scale score \<15, a respiratory rate ≥22, or a systolic blood pressure ≤90 mmHg or a mean arterial pressure of ≤65 mmHg)
• • 5. Resident within a pre-defined geographic area to ensure TB clinic follow-up
• • 6. For females of reproductive potential: use of highly effective contraception through 28 days
• Exclusion Criteria:
• • 1. Known active TB or receiving anti-TB therapy
• • 2. Pregnancy or lactation. Women will undergo urine pregnancy screening. Pregnant women will be excluded due to the possible toxicity and teratogenicity of high dose rifampin and isoniazid included in anti-TB therapy as well as possible teratogenicity of dolutegravir which is recommended as first-line antiretroviral therapy in this study.
• • 3. Known allergic reactions to the components of the anti-TB therapy
• • 4. Treatment with another investigational drug or other intervention within one month
• • 5. Known liver disease
• • 6. Alcohol use \> 14 standardized drinks per week and/or \> 4 drinks per day for men and \>7 standardized drinks per week and/or \>3 drinks per day for women, defined as 14 grams of ethanol, as found in example 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of 80 proof spirits
• • 7. Positive serum cryptococcal antigen test
• • 8. Current treatment with a drug known to have significant interaction with anti-TB therapy