The BEAT Tuberculosis trial in South Africa has broken ground by including pregnant women with drug-resistant tuberculosis (TB), a population frequently excluded from clinical trials. This inclusion addresses a significant gap in evidence-based treatment for pregnant women, who face heightened risks and limited therapeutic options.
Addressing a Critical Gap in TB Treatment
Pregnant women are often excluded from TB drug trials due to concerns about potential harm to the developing fetus, leading to a lack of data on the safety and efficacy of TB treatments during pregnancy. The World Health Organization (WHO) estimates that approximately 200,000 pregnant women develop TB annually, increasing the risk of prematurity, low birth weight, and stillbirths.
Dr. Francesca Conradie, an infectious diseases researcher at the University of the Witwatersrand (Wits) and the principal investigator of the BEAT Tuberculosis trial, emphasized the importance of including pregnant women in TB research. "Pregnant women can get sick with TB and women sick with TB can get pregnant," she stated. "Aside from the potential risks for an unborn baby, pregnancy is an altered physiological state. The health of the mother is paramount for a good outcome of a pregnancy."
BEAT Tuberculosis Trial Details
The BEAT Tuberculosis trial enrolled 402 participants with drug-resistant TB between 2019 and 2021. While pregnant women were not initially included, the study protocol was amended to allow their participation. Ultimately, ten pregnant women were enrolled, with six receiving a short-course treatment regimen containing delamanid.
"This may sound like a few, but it is more than any other study in the world. We had 10 healthy babies born. In addition, nine out of the 10 women were successfully treated," Dr. Conradie noted. The trial's findings provide valuable data supporting the use of delamanid-containing regimens in pregnant women with drug-resistant TB.
Implications for Treatment Guidelines
The inclusion of pregnant women in the BEAT Tuberculosis trial and the positive outcomes observed are expected to influence TB treatment guidelines. Dr. Conradie indicated that South Africa is already incorporating these findings into its national guidelines. "All pregnant women with drug-resistant TB are presented to the National Clinical Advisory Committee and this is approved by this group. Globally it will take a bit longer."
Professor Keertan Dheda, head of the University of Cape Town’s Division of Pulmonology and Respiratory Services at Groote Schuur Hospital, noted that the study provides data that will make clinicians more comfortable with prescribing delamanid for pregnant women.
This study marks a significant step forward in addressing the unmet needs of pregnant women with TB, offering the potential for improved treatment outcomes and healthier pregnancies.
