Request for Expressions of Interest to Conduct a Clinical Study on a Novel Treatment for Intra-amniotic Infection/Inflammation and Chorioamnionitis
Intra-amniotic inflammation (IAI) or chorioamnionitis is a common complication of pregnancy producing significant maternal morbidity/mortality, premature birth and neonatal risk of chronic lung diseases such as bronchopulmonary dysplasia (BPD). Current management of IAI or chorioamnionitis involves prompt initiation of broad-spectrum antibiotics to significantly reduce maternal and fetal complications of chorioamnionitis. Unfortunately, antibiotic usage has failed to show a significant impact on preterm labor or major comorbidities of chorioamnionitis after birth.
The South African Medical Research Council (SAMRC) is exploring a collaboration with a US-based company to test the safety and efficacy of a novel monoclonal antibody for the treatment of IAI and chorioamnionitis in South Africa. The study will be a Phase 1 randomized, placebo-controlled study in 18 pregnant women with intra-amniotic inflammation/infection in two hospital sites. The study’s primary objective is to test the safety and tolerability of a single intravenously (IV) infused dose of the antibody and the secondary objectives include evaluation of the impact on premature births and neonatal outcomes. The ultimate aim is to examine the potential for a novel treatment for IAI and chorioamnionitis in the South African setting.
We are seeking experienced obstetricians based at publicly funded institutions with access to clinical research facilities and relevant participant populations who are interested in participating as investigators on the study. Investigators must have experience in conducting clinical trials in pregnant women and access to suitable facilities for hospitalization of participants throughout the study, including for neonatal and postnatal care. Interested parties must please complete an Expression of Interest using the following online form: Expressions of Interest to Conduct a Clinical Study on a Novel Treatment for Intra-amniotic Infection/Inflammation and Chorioamnionitis.
Deadline for submissions: 19 July 2024
The Expressions of Interest received will be used to select potential investigators and facilities for the study who will then be required to sign a non-disclosure agreement before receiving the protocol and study details. They will then be requested to submit a proposal and budget for the study. Investigators to conduct the study will be selected based on relevant experience, available infrastructure and budget.
Please note that this is not a funding call and at this stage the EOI process does not guarantee any financial support to applicants or the inclusion of the applicants in the clinical study. The SAMRC reserves the right not to select any investigators and facilities responding to this call, not to proceed with the study and/or to request adjustments to the budgets submitted by those selected in the first round.
For more information, please contact:
Smangele Malema
Project Coordinator
Grants Innovation and Product Development (GIPD)
South African Medical Research Council
Email: GIPD.applications@mrc.ac.za
Tel: +27 21 938 0840