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Clinical and Biomedical Research

On-going Studies

COAST

Children’s Oxygen Administration Strategies Trial (COAST): a randomised controlled trial of high flow versus oxygen versus control in African children with severe pneumonia. Although giving oxygen is a basic element of hospital care, this treatment is costly and supplies are inadequate and erratic in African hospitals. The aim of this study is to identify which children would benefit from receiving oxygen and what would be the best delivery method.

Participants of the study are restricted to Children aged between 28 days and 12 years with a history of respiratory illness, hypoxia (lack of adequate oxygen supply) and signs of severe pneumonia (lung inflammation). This study examines whether or not giving oxygen improves patient outcomes. For children with hypoxia, it is not certain what the best level to provide oxygen is and whether this results in a better outcome.

REACH

Realizing Effectiveness Across Continents with Hydroxyurea (REACH) is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for children with confirmed Sudden Cardiac Arrest (SCA) between 12 months and 10 years. objectives of the study include:

1. To assess the feasibility of conducting a prospective research study using hydroxyurea therapy for SCA in sub-Saharan Africa (including adherence to monthly clinic visits and laboratory assessments, and medication compliance)

2. To monitor the safety of hydroxyurea therapy, specifically documenting haematological toxicities (cytopenia) and serious infections (bacterial and malarial)

3. To evaluate the benefits of hydroxyurea therapy, using both laboratory (e.g., foetal haemoglobin, haemoglobin, white blood cell count) and clinical parameters (e.g., pain, hospitalization, growth)

TRACT

The Transfusion and Treatment of severe Anaemia in African Children (TRACT) is a randomised controlled Trial. TRACT is evaluating three different ways to reduce short and longer-term mortality and morbidity following admission to hospital with severe anaemia in African children.

TRACT will therefore compare three different ways that outcomes could be improved:

• Liberal transfusion (30ml/kg whole blood) versus conservative transfusion (20ml/kg) versus no transfusion (control). The control is only for children with uncomplicated severe anaemia (haemoglobin 4-6 g/dl);

• Post-discharge multi-vitamin multi-mineral supplementation (including folate and iron) versus routine care (folate and iron) for 3 months;

• post-discharge cotrimoxazole prophylaxis for 3 months versus no prophylaxis.

PAC

PAC stands for Primaquine in African Children. The clinical trial mainly involves assessing the tolerability and safety of SLDPQ - Single Low Dose Primaquine in African Children with acute uncomplicated falciparum malaria and glucose 6 phosphate dehydrogenase deficiency. PAC uses the SLDPQ in the management of of uncomplicated malaria in African Children.

TABS PKPD

TABS PKPD is clinical trial involving the investigation of Pharmacokinetics and Pharmacodynamics of Azithromycin in severe malaria and baterial co-infection in African Children. The key objectives include: to establish the dose for oral dispersible Azithromycin as an antimicrobial treatment for children with severe malaria, and investigate the antibiotics that can be targeted to those at great risk of baterial co-infection using clinical criteria alone or in combination with rapid diagnostic biomarker tests.

GASTRO

Gastroenteritis aggressive versus slow treatment for rehydration (GASTRO). Gastroenteritis is a very common cause of diarrhea and vomiting. It is most likely to be caused by a bacterial or viral stomach infection and is particularly common in young children. This trial study is conducted at MCRI. In some cases, it can cause severe dehydration, a condition that requires immediate medical treatment. Worldwide, an estimated 2.5 billion cases of acute gastroenteritis causing diarrhea and vomiting occur every year in children under 5 years.

FLACSAM

FLACSAM stands for Firstline Antimicrobials in Children with Complicated Severe Acute Malnutrition. The study compares antibiotics used in managing infections in children. This is a clinical trial comparing effectiveness of antibiotics used to treat children with complicated severe acute malnutrition.

It’s a common practice among clinicians to prescribe Ceftriaxone, a second line treatment medication for such children even before starting with a combination of a penicillin and Gentamycin as stipulated in the treatment guidelines.

Another observation has been that there is a tendency to prescribe Metronidazole for children with malnutrition in addition to other antibiotics yet there has not been any known scientific study pointing to the added benefit of such practice.

This study therefore employs a 2 by 2 multifactorial design to assess the relevance of Metronidazole in management of children with malnutrition and to also assess the suspected resistance that might come up as a result of prescribing antibiotics without following the established guidelines.