Clinical trials: active, in Malawi
Malaria, Cerebral
DON in Pediatric Cerebral Malaria
The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 12 months-14 years old with clinically defined Cerebral Malaria.
- Trial name
- NCT05478720
- Testing
- 6-diazo-5-oxo-L-norleucine (DON)
- Where
- 2 sites in Malawi
- Volunteers
- 152 people
- Sponsor
- Douglas Postels, MD, MS
Syphilis, Congenital
Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
CARES-1 is a randomised, open-label, phase II pharmacokinetic (PK) and safety study of ambulatory antibiotics for the treatment of neonates with "all-risk" asymptomatic congenital syphilis.
- Trial name
- Cares-1 (NCT06921213)
- Testing
- Linezolid (LZD), Amoxicillin, Benzathine Penicillin G
- Where
- 3 sites in Indonesia, Malawi and 1 more
- Volunteers
- 90 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Sexually Transmitted Infection (STI), Gonorrhea
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
This study is for people who may get sexually transmitted infections (STIs). Approximately 580 African adolescent and young adult women ages 13-34 in Africa will be included in this study.
- Conditions
- Sexually Transmitted Infection (STI), Gonorrhea, Syphilis, Chlamydia
- Trial name
- NCT07884240
- Testing
- Doxycycline hyclate, Standard of Care for STI prevention
- Where
- 4 sites in Botswana, Eswatini and 2 more
- Volunteers
- 580 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pulmonary Tuberculosis
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary…
- Trial name
- RAD-TB (NCT06192160)
- Testing
- Isoniazid, Rifampicin, Pyrazinamide
- Where
- 30 sites in Botswana, Brazil and 12 more
- Volunteers
- 315 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Skin Ageing, Skin
Skin Type Determination Using Image Artificial Intelligence
Skin color, how easily a person burns or tans in the sun (skin phototype), and the amount of chronic sun damage in the skin are important factors in skin health.
- Trial name
- SPAI (NCT07765303)
- Testing
- Skin imaging and skin characteristic assessment
- Where
- 13 sites in Australia, Brazil and 9 more
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Region Skane
Breastfeeding, HIV Prevention
Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
The goal of the Leveraging Infant Visit PrEP INtegration \& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package ("LINK model") among…
- Trial name
- LINK (NCT06506188)
- Testing
- LINK model
- Where
- Malawi
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Prevention
Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
Purpose: To conduct a hybrid effectiveness-implementation stepped-wedge trial to: 1. Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of infants who receive timely EID testing. 2.
- Trial name
- PAC-Man (NCT06493357)
- Testing
- PAC-Man, Standard of Care
- Where
- 3 sites in Malawi
- Volunteers
- 2,426 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Typhoid
Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
This study will evaluate the efficacy of a Typhoid conjugate vaccine (Vi-TCV) in Malawi, Africa among children age 9 months through 12 years.
- Trial name
- NCT03299426
- Testing
- Vi-Typhoid Conjugate Vaccine (Vi-TCV), Meningococcal A Conjugate Vaccine (MCV-A)
- Where
- Malawi
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Acute Hypoxemia
Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation
Acute hypoxemia is common and deadly in resource variable settings. While studies in high income countries (HICs) have indicated a possible benefit to high flow oxygen as compared with standard flow oxygen, rigorous studies in…
- Trial name
- BREATHE (NCT05754034)
- Testing
- High flow oxygen, Standard flow oxygen
- Where
- 5 sites in Kenya, Malawi and 1 more
- Volunteers
- 1,600 people
- Sponsor
- Beth Israel Deaconess Medical Center
Lymphoma, Hematologic Malignancies
Clinical Cohort of Lymphoma Patients in Malawi
This registry study is intended to establish a large prospective longitudinal clinical cohort of lymphoma patients in Malawi, as such data is currently lacking from sub-Saharan Africa.
- Trial name
- NCT02835911
- Where
- Malawi
- Volunteers
- 1,140 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Pneumonia, Pneumonia - Bacterial
Urine Pneumococcal Antigen Project
Background: Pneumonia caused by the bacteria Streptococcus pneumoniae is a leading cause of death among children under five years of age, especially in sub-Saharan Africa.
- Trial name
- UPAP (NCT07181200)
- Where
- Malawi
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Preterm Birth, Low Birthweight Neonate
Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial
The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact…
- Conditions
- Preterm Birth, Low Birthweight Neonate, Periodontitis, Gingivitis
- Trial name
- XaPPP (NCT07424846)
- Testing
- Xylitol Chewing gum, Sorbitol chewing gum
- Where
- Malawi
- Volunteers
- 6,000 people
- Sponsor
- University of Washington
HIV Infection
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among…
- Trial name
- NCT02140255
- Testing
- Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Nevirapine (NVP), Lopinavir/Ritonavir (LPV/r)
- Where
- 47 sites in United States, Argentina and 11 more
- Volunteers
- 1,120 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults
The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered…
- Trial name
- NCT06062238
- Testing
- M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine
- Where
- 54 sites in Indonesia, Kenya and 3 more
- Volunteers
- 20,080 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
HIV, Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease
New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease
Persons living with HIV (PLWH) in sub-Saharan Africa (SSA), lymphadenopathy often portends one of a number of life-threatening diseases including tuberculosis, lymphoma, and multicentric Castleman disease (MCD).
- Conditions
- HIV, Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease, Hodgkin Lymphoma, Non-Hodgkin Lymphoma
- Trial name
- NCT07793006
- Testing
- Lymph Node or Core Needle Biopsy, Fine Needle Aspiration, Tiny Isothermal Nucleic acid Amplification System (TINY)
- Where
- Malawi
- Volunteers
- 500 people
- Sponsor
- Indiana University
Prematurity, Neurodevelopmental Disorders
Prevention of Developmental Delay and Xylitol (PDDaX) Study
The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as…
- Trial name
- NCT05361122
- Testing
- Maternal Use of Xylitol Chewing Gum During Pregnancy, No Maternal Xylitol Chewing Gum Use During Pregnancy
- Where
- Malawi
- Volunteers
- 1,000 people
- Sponsor
- University of Washington
Tuberculosis
A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)
The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome.
- Trial name
- NCT07595042
- Testing
- Isoniazid, Rifampin, Pyrazinamide
- Where
- 29 sites in Argentina, Australia and 14 more
- Volunteers
- 900 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Severe Acute Malnutrition, Cognitive Impairment
Choline to Improve Malnutrition and Enhance Cognition
The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi.
- Conditions
- Severe Acute Malnutrition, Cognitive Impairment, Wasting, Kwashiorkor
- Trial name
- CHIME-SAM (NCT06154174)
- Testing
- C-RUTF (Ready-to-Use Therapeutic Food with added choline), S-RUTF (Ready-to-Use Therapeutic Food without added choline), Amoxicillin
- Where
- 10 sites in Malawi
- Volunteers
- 1,500 people
- Sponsor
- Washington University School of Medicine
Cervical Cancer Prevention
Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention
The goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase cervical cancer prevention in Malawi. The main questions it aims to answer are: 1.
- Trial name
- NCT07015957
- Testing
- In-person training, Virtual training, Coaching
- Where
- Malawi
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- New York University
HIV Infections
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN…
- Trial name
- PALISADE (NCT06134362)
- Testing
- CAB LA
- Where
- 33 sites in Argentina, Botswana and 10 more
- Volunteers
- 2,996 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare