There are about 176 clinical studies being (or have been) conducted in Zambia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study is a multi-centre interventional study at seven tertiary paediatric surgery centres in Ghana, Zambia, Malawi and Tanzania aimed at reducing mortality from gastroschisis.
The TAME study will evaluate four new approaches which will be compared against the standard care currently in use in the treatment of malnutrition enteropathy in children with severe acute malnutrition. A high pathogen burden causes damage to the intestinal mucosa which exacerbates nutritional impairment and leads to further susceptibility to infection and impaired epithelial regeneration. Enteropathy is characterised by multiple epithelial breaches, microbial translocation from gut lumen to systemic circulation and systemic inflammation.The trial will evaluate the potential impact of four interventions (colostrum, N-acetyl glucosamine, teduglutide, and budesonide) given for 14 days, which aim at mucosal restoration. The trial will determine if repairing damage to the small intestinal mucosa leads to the reduction of systemic inflammation and thus lessening the nutritional impairment, and so if this contributes to the reduction of mortality in children. In Zambia only, endoscopic biopsies and confocal laser endomicroscopy will be used to evaluate response and confirm safety at a mucosal level. Identifying an agent or agents which contribute most to mucosal healing will then ultimately lead to further large phase 3 trial in which the agent(s) will be further evaluated. The trial also anticipates to gain a more in depth understanding of pathophysiology and may identify where current management strategies of treating malnutrition enteropathy in children are failing.
Tuberculosis and HIV continue to be major public health problems in resource constrained settings like Zambia. Zambia is among the top 30 highest burden countries globally. The major drivers of TB in the Africa region is the HIV epidemic. Inadequate TB diagnostic tools with failure to make a timely diagnosis and start appropriate treatment are the major impediments to TB control in Zambia and globally.
Background: In developing countries, micronutrient deficiency in infants is associated with growth faltering, morbidity, and delayed motor development. One of the potentially low-cost and sustainable solutions is to use locally producible food for the home fortification of complementary foods. Objective: The objectives are to test the hypothesis that locally producible spirulina platensis supplementation would achieve the following: 1) increase infant physical growth; 2) reduce morbidity; and 3) improve motor development. Design: 501 Zambian infants are randomly assigned into a control (CON) group or a spirulina (SP) group. Children in the CON group (n=250) receive a soya-maize-based porridge for 12 months, whereas those in the SP group (n=251) receive the same food but with the addition of spirulina. The change in infants' anthropometric status, morbidity, and motor development over 12 months are assessed.
General objective - To assess the long-term safety and efficacy of one-year infant prophylaxis using lamivudine (3TC) or lopinavir/ritonavir (LPV/r) to prevent post-natal transmission through breastfeeding. - To investigate the biological mechanisms involved in postnatal HIV transmission. Specific objectives - To compare the long-term safety of infant prophylaxis using either 3TC versus LPV/r on child development (growth, somatic and mental health), mortality, adrenal function, liver function, full blood count and mitochondrial toxicity. - To estimate the final efficacy data of 50 weeks of infant prophylaxis using either LPV/r or 3TC, since some mothers may have resumed breastfeeding after the trial. - To profile miRNA in breast milk according to maternal HIV status and HIV transmission. - To determine the influence of maternal milk on infant gut inflammation in an in vitro 3D-intestinal model (CACO-2 cells). The study population will comprise all ANRS 12174 PROMISE-PEP trial participants who completed the 50 week follow-up and are not HIV infected. An estimate of 881 mother-child pairs from the ANRS 12174 PROMISE- PEP will be recruited. This study is structured in two parts. The 'clinical & biological safety' component involves a cross sectional survey. A clinical and neuropsychological examination of participants will be conducted. In addition one venous blood sample will be collected to evaluate children HIV status, full blood count, liver & adrenal function and mitochondrial toxicity. Capillary hair follicles will be collected from 100 children in Zambia to study their genome integrity. The 'mechanisms' component includes biological assays to be conducted on breast milk samples previously collected from HIV infected, transmitting or non-infected mothers enrolled at ANRS 12174 PROMISE-PEP trial. Primary endpoint: Long term survival, mortality rate, measurements of infant growth (length and weight), somatic and neuropsychological development of the 5 year old children enrolled in the ANRS 12174 PROMISE- PEP trial. Secondary endpoints: HIV seroconversion since last PROMISE PEP trial visit, full blood count, liver function, adrenal function, serum lactate. Number of mitochondrial DNA copies per cell & percentage of mitochondrial DNA deletion for mitochondrial toxicity. Number of micronuclei & number of Ɣ-tubulin spot per cell to study genomic toxicity.
To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.
The study will examine whether prophylactic and scheduled treatment with acetaminophen and ibuprofen can decrease the maximum temperature experienced during the acute illness in children with CNS malaria.
Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which, 2.86 million (range: 1.3-4.0 million) will contract cholera and 95,000 (21,000-143,000) will die each year. A safe, effective, and affordable killed whole-cell oral cholera vaccine (OCV) is now being used widely to prevent cholera in areas at risk. This regimen demonstrated 65% efficacy retained for at least 3 years and even up to 5 years in an endemic setting. The primary aim of this project is to determine changes in the vibriocidal geometric mean titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at different intervals: 2 weeks, or 6 months following the first dose of vaccine. Secondary aims include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks or 6 months following the first dose of vaccine, b) age specific serum vibriocidal GMTs following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine, c) GMT and antibody response rates of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (anti-LPS) as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine. Our hypothesis is that the vibriocidal GMT following the second dose, when given after 6 months will not be inferior to the response when the second dose is given according to the standard interval of two weeks.
Infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours will be randomized to either standard protocol of open crib or mylar-lined cardboard cot for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care.
This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to traditional incubators in their ability to prevent hypothermia (axillary temperature < 36° C) in preterm neonates <36 6/7 weeks gestational age in a randomized cross-over designed trial. Infants will be randomized to receive care in the cardboard cot or incubator and then cross over to the other device for 24 hour periods, rotating for a total of 96 hours total trial time.