Country: South Africa   -  Stage: 1 & 2


MDR-TB burden: 21 per 100,000
No. of trial sites: 4
Date first patient recruited: August 2012
WHO Fact sheet: Click here

 

The South African TB epidemic is largely driven by a high HIV prevalence. In 2017, estimated incidence for TB was 567 per 100 000 population and the mortality rate was 138 per 100 000 population. For the same year, 227,224 TB cases were notified. It is also estimated that 3.4% of new TB cases and 7.1% of all previously treated cases were MDR/RR-TB. In 2017, 10,259 patients started treatment for MDR/RR-TB.

KwaZulu Natal Province is the hotspot of Drug-Resistant TB and was where the first documented outbreak of XDR-TB occurred. King DiniZulu Hospital Complex is located in Durban and at the time of the start of STREAM Stage 1 was the referral site for all MDR-TB cases in the province. This hospital with over 1200 beds offers both TB and psychiatric services. The site is managed by Wits Health Consortium. For STREAM Stage 1, a total of 165 patients were enrolled from three sites in South Africa. In total, 90 patients were enrolled in the STREAM Stage 1 at King DiniZulu Hospital Complex in Durban.

The mission of Doris Goodwin Hospital, located in Pietermaritzburg, also in KwaZulu Natal, is to be a center of excellence in providing high quality medical services for managing MDR-TB as well as specialized, sub-acute, and recurring TB. This hospital which serves patients with 100 beds was operated by an NGO, Santa for TB Management. It was then taken over by the government and later became specialized in MDR-TB management. A research site was established by THINK to conduct STREAM Stage 1. At the Doris Goodwin Hospital in Pietermaritzburg, 14 patients were recruited for Stage 1.

The Sizwe Tropical Disease Hospital is the referral hospital for patients within Gauteng Province, the most populous province in South Africa. Formally a fevers hospital, the location of the facility is ideal for admission and treatment of infectious MDR- and XDR-TB patients. In 2008, a clinical trial facility was established on the premises by Wits Health Consortium. Following the successful implementation of the registrational trials for bedaquiline, STREAM Stage 1 began enrollment in August 2012. A total of 61 patients were enrolled at the Sizwe Hospital in Johannesburg. Given the successful implementation of Stage 1 in South Africa, King DinuZulu Hospital and Doris Goodwin Hospital were chosen to continue into Stage 2 of the trial. South Africa was the third country to initiate STREAM Stage 2 and began recruitment in September 2016.

A new site in Johannesburg, the Helen Joseph Hospital, joined the existing sites. Helen Joseph Hospital is a tertiary care hospital in Johannesburg, South Africa. It provides services to a population of about 1 million. The hospital has 21 inpatient wards, most being for adult medical admissions. In addition, there are 6 surgical wards, Psychiatric unit, a 10-bed ICU, a 12 bed-High Care/Step down unit, a Theatre complex. There are no pediatric or OBG/GYN services. In addition, there are a number of outpatients’ services including Stoma unit, Renal dialysis unit, Pain clinic, Endoscopy unit, Breast clinic, the TB focal point, and the Themba Lethu HIV clinic. Housed within the hospital is the Clinical HIV Research Unit, a division of Wits Health Consortium. At this site, a number of clinical trials are being done, including STREAM Stage 2.

A fourth site in the Eastern Cape began recruitment in March 2018. Empilweni TB Hospital is a specialized TB hospital and accepts referrals for both drug resistant and drug-resistant TB on the outskirts of Port Elizabeth in the Eastern Cape. The facility has 330 beds with dedicated beds for in-patient treatment of MDR TB. It is a decentralized MDR-TB treatment facility. STREAM Stage 2 will be the first clinical trial to be conducted at this hospital, which will build capacity in this community for research.

The South African sites are expected to recruit more than 90 patients into STREAM Stage 2.