Completed Studies

Completed Research Initiatives.

Over the years, Mbale Clinical Research Institute (MCRI) has successfully completed numerous studies that have contributed significantly to public health knowledge and practice. These studies have addressed a range of critical issues, from improving nutritional assessments to enhancing disease prevention strategies in low-resource settings. Each completed project has provided valuable data and insights, helping shape health policies and informing future research directions. MCRI’s work has not only advanced scientific understanding but has also had a meaningful impact on community health by providing evidence-based recommendations that support sustainable development and improved health outcomes.

NUTIP

Nutritional Intervention in Pneumonia Trial (NuTiP)

NuTiP is a multicentre randomised controlled trial evaluating whether short-term nutritional support improves recovery among children hospitalised with severe pneumonia and hypoxia. The study planned to enrol 840 children aged 6 months to 12 years across hospitals in Uganda and Kenya. Participants received either daily ready-to-use therapeutic food for 56 days alongside their usual diet or usual care alone. The study assessed nutritional recovery, mortality, hospital readmission and longer-term health outcomes over six months.

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PAC

Primaquine in African Children Study (PAC)

PAC was a multicentre clinical trial evaluating the safety of adding a single low dose of primaquine to standard malaria treatment in African children, including those with glucose-6-phosphate dehydrogenase deficiency. Conducted in Uganda and the Democratic Republic of the Congo, the study enrolled 1,137 children with uncomplicated falciparum malaria. Primaquine was well tolerated, with a safety profile comparable to placebo. The findings support wider use of single low-dose primaquine to reduce malaria transmission in Africa.

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TABS PKPD

Pharmacokinetics and Pharmacodynamics of Azithromycin in Severe Malaria Bacterial Co-infection in African Children

TABS PKPD is clinical trial involving the investigation of Pharmacokinetics and Pharmacodynamics of Azithromycin in severe malaria and Bacterial 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 Bacterial co-infection using clinical criteria alone or in combination with rapid diagnostic biomarker tests.

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FLACSAM

First-Line Antimicrobials in Children with Complicated Severe Acute Malnutrition.

The FLACSAM Study was a multicentre clinical trial evaluating improved first-line antibiotic treatment for children admitted with complicated severe acute malnutrition. Conducted in Kenya and Uganda, including Mbale Regional Referral Hospital, it compared ceftriaxone with standard antibiotic treatment and assessed the additional value of metronidazole. The study examined mortality, nutritional recovery, antimicrobial resistance, drug dosing and treatment costs, generating evidence to improve treatment guidelines for vulnerable malnourished children in African hospitals.

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MIMBLE II

Modifying Intestinal Integrity and Microbiome in Malnutrition with Legume-Based Feeds.

The MIMBLE Study investigated whether locally relevant legume-enriched nutritional feeds could improve recovery in Ugandan children hospitalised with severe acute malnutrition. Conducted at Mbale Regional Referral Hospital, the research compared modified feeds containing fermentable carbohydrates with standard WHO therapeutic milk feeds. It assessed survival, nutritional recovery, diarrhoea, intestinal health and changes in the gut microbiome. The findings showed that legume-based feeds produced nutritional outcomes comparable to standard feeds and supported further development of gut-focused treatments for severe malnutrition.

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TRACT

Transfusion and Treatment of Severe Anaemia in African Children.

The TRACT Study was a large multicentre clinical trial that evaluated blood-transfusion and post-discharge treatment strategies for African children hospitalised with severe anaemia. Conducted in Uganda and Malawi, including at Mbale Regional Referral Hospital, the study enrolled 3,199 children. It examined when transfusion should begin, the appropriate volume of blood, and whether nutritional supplementation or cotrimoxazole could improve recovery. Its findings have provided important evidence for safer and more effective management of severe childhood anaemia.

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FEAST

Fluid Expansion as Supportive Therapy Trial (FEAST)

FEAST was a multicentre randomised controlled trial investigating fluid-resuscitation strategies in 3,170 critically ill African children with severe infections and impaired circulation. Conducted at hospitals in Uganda, Kenya and Tanzania, it compared rapid fluid boluses using saline or albumin with maintenance fluids alone. The trial found that fluid boluses increased mortality compared with maintenance fluids. These unexpected findings significantly influenced understanding of paediatric emergency care and fluid management in resource-limited African hospitals.

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COCS

Coronavirus Disease 2019 Open Cohort Study (COCS)

The Coronavirus Disease 2019 Open Cohort Study was designed to strengthen understanding of COVID-19 case definitions, epidemiology, clinical presentation and outcomes. It combined a voluntary global online cohort with retrospective and prospective hospital surveillance at Mbale and Soroti Regional Referral Hospitals. The project examined COVID-19 risk factors, co-infections, hospitalisation and mortality, and assessed how the pandemic affected other major diseases. Its findings were intended to support evidence-based surveillance, public-health communication, clinical research and future outbreak preparedness.

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COAST

Gastroenteritis is a very common cause of diarrhoea 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 was conducted at MCRI.

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GTS

Development of Geospatio-Temporal Surveillance and Characterisation of Malaria in the Changing Climatic Conditions in Eastern Uganda Study.

The GTS-MACS Study investigates how changing temperature, rainfall and humidity affect malaria transmission across Eastern, Northern and Northeastern Uganda. Led by Busitema University and Mbale Clinical Research Institute, the study combines geospatial surveillance, parasite-clearance monitoring and molecular analysis of antimalarial-resistance markers. Its findings have identified geographical differences in malaria patterns and emerging resistance-associated mutations, providing evidence to strengthen surveillance, guide treatment policies and support targeted malaria-control interventions in Uganda.

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GASTROSAM

Gastroenteritis Rehydration of Children with Severe Acute Malnutrition (GASTROSAM): A Phase II Randomised Controlled Trial.

GASTROSAM was a multicountry clinical trial investigating safer and more effective ways to rehydrate children with severe acute malnutrition and diarrhoea. Conducted in Uganda, Kenya, Niger and Nigeria, the study compared oral and intravenous rehydration strategies in children aged 6 months to 12 years. Its findings showed that carefully monitored intravenous fluids and standard WHO oral rehydration solution can be used safely, providing important evidence for simplifying international treatment guidelines.

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GASTRO

Gastroenteritis Aggressive Versus Slow Treatment for Rehydration (GASTRO): A Phase II Rehydration Trial for Severe Dehydration—WHO Plan C Versus Slow Rehydration.

The GASTRO Study evaluated two intravenous rehydration strategies for children admitted with severe dehydration caused by acute gastroenteritis. Conducted in Uganda and Kenya, the trial compared the standard WHO Plan C regimen with a simpler, slower eight-hour infusion. Both approaches produced similar clinical outcomes, with no evidence that slower rehydration increased serious adverse events. The findings supported further research into safe, practical rehydration protocols for critically ill African children.

 

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About

Ms. Adyango Catherine is a Human Resource Manager and Senior Grants Professional with over 15 years of experience in managing multimillion-dollar donor portfolios, project operations, and organizational systems strengthening. She currently serves as Human resource Manager at Mbale Clinical Research Institute (MCRI), where she leads in Human resource management,  donor compliance, project operations, and institutional capacity building.

At MCRI, Catherine has combined her expertise in grant management and human resources to establish efficient systems that support both research and staff welfare. She played a pivotal role in championing organizational culture reforms, developing HR policies, strengthening staff welfare schemes, and promoting inclusive recruitment processes. She also streamlined adoption of a Human Resource Management Information System (HRMIS/ESS), which reduced administrative bottlenecks and improved efficiency across teams.

Her academic background includes a Postgraduate Diploma in Human Resource Management (Uganda Management Institute), an MSc in Health Services Management, and a bachelor’s degree in business administration & management. Catherine is also pursuing ACCA training, demonstrating her commitment to continuous professional growth.

Catherine’s career reflects a strong commitment to strategic leadership, staff development, and inclusive programming, with a proven ability to balance donor expectations and human resource needs. Her work at MCRI has significantly contributed to building sustainable research capacity, enhancing compliance systems, and creating a supportive work environment that empowers both researchers and administrative staff.

About

Denis Amorut serves as the Study Site Coordinator at the Mbale Clinical Research Institute’s Soroti Site. He is a qualified Registered Nurse with a Bachelor of Science in Health Services Management from the Islamic University in Uganda and a Diploma in Comprehensive Nursing from Soroti School of Registered Comprehensive Nursing. Additionally, he is currently pursuing an Advanced Postgraduate Diploma in Clinical Research & Quality Assurance at James Lind Institute, showcasing his commitment to advancing his expertise in clinical research. Denis has an extensive professional background with 12 years in clinical nursing practice and 11 years dedicated to clinical research. He is registered with the Uganda Midwives and Nurses Council, highlighting his professional standing in the healthcare sector.
 
Throughout his career, Denis has held significant positions such as Trial Manager since November 2021 and previously as Study Site Coordinator at Soroti Regional Referral and Teaching Hospital from 2008 to October 2021. He also serves as a member of the Medicine and Therapeutic Committee at the same hospital since 2018. Denis has enriched his knowledge and skills through numerous online courses and certifications in areas like research ethics, data management for clinical studies, Good Clinical Practice (GCP), and managing health emergencies like Covid-19. His involvement in various research studies, including the TRACT study, and his roles in hospital committees further demonstrate his dedication to both practice and research in healthcare, focusing on improving patient care through evidence-based practices.

About

Ms. Linda Isabirye serves as the Public and Community Engagement Officer at MCRI, where her role encompasses a variety of tasks aimed at enhancing the Institute’s interaction with both internal and external communities. Her work is divided into two primary focuses: public engagement, where she communicates the Institute’s research and ideas to the public, and community engagement, where she assists others in conducting research and achieving their objectives.

In her community engagement efforts, Linda is involved in developing and sustaining a public engagement and involvement framework for the research program. She identifies local opportunities for community collaboration, nurturing relationships with MCRI’s research scientists, staff, and the broader community.

With over two years of experience, she has worked extensively with diverse community stakeholders. Her responsibilities include coordinating activities for the Community Advisory Board (CAB), designing, and overseeing the execution of Community Engagement (CE) initiatives. These initiatives are crucial for identifying, recruiting, and retaining volunteers, engaging community leadership, and supporting the formation and operation of community peer groups. This includes working with study participants, family support groups, and youth and adolescent groups, among others.

About

Rita Muhindo holds a MSc. Molecular Biology from Staffordshire University, UK. She attained her BSc. Biomedical Laboratory Science and Technology degree from Makerere University and an Advanced Diploma in Health Services Management from Islamic University in Uganda. She joined Mbale Clinical Research Institute in July 2011 as a laboratory technologist participating in setting up various laboratory assays for all clinical trials at the MCRI.

She is currently the laboratory manager of MCRI, a role which involves supervision all laboratory research activities at MCRI main and satellite laboratories. She has over twelve years of experience in managing laboratory clinical research and diagnostics service delivery across several key disciplines including molecular, immunology, hematology, microbiology and clinical chemistry.

She has keen interest in understanding the prevalence of red cell polymorphisms present in Ugandan donor populations. Her main focus of her MSc project was on the prevalence of Glucose-6-Phosphate dehydrogenase deficiency, α-thalassaemia and Haemoglobin S among Ugandan donors. Rita is also keen to explore the effects of these polymorphisms on the resolution of severe anaemia.

About

Dr. Charles Benard Okalebo is a highly qualified professional with a B. Pharm, an MPH, and currently a fellow in Infectious Disease and Field Epidemiology under the EDCTP-funded IDEA fellowship. His background as a pharmacist and public health specialist, combined with his role as a Quality Assurance Officer, has provided him with extensive experience in clinical research. This diverse training has honed his skills in assessing healthcare gaps, identifying problems, and designing projects to address these deficiencies. Dr. Okalebo values accuracy, integrity, quality, and career growth above all.
 
He is an experienced and determined professional in conducting clinical trials for both infectious and non-infectious diseases. With eight years in the research field, he has served as a Pharmacist and Quality Assurance Officer at the Mbale Clinical Research Institute, focusing on various types of clinical trials related to infectious diseases. His involvement spans across all phases of clinical trials (I-III), including protocol design, review, and implementation; navigating regulatory approval processes; managing investigational medicinal products (IMP); monitoring studies; establishing and implementing Quality Management processes; pharmacovigilance; and leading training sessions on the ethical conduct of research. The trials he has participated in include TRACT (ISRCTN84086586), GASTROSAM (ISRCTN76149273), PAC (ISRCTN11594437), FLACSAM (ISRCTN18051843), MIMBLE (ISRCTN10309022), and TABS (ISRCTN49726849) studies.
 
Dr. Okalebo is a dedicated researcher with a keen interest in advancing his career in pharmaco-epidemiology, statistics, and pharmacovigilance.

About

Felix Opio joined the Mbale Clinical Research Institute (MCRI) in April 2014 as Data Manager under the REACH (Realizing Effectiveness Across Continents with Hydroxyurea) ClinicalTrials.gov NCT01966731) which is a prospective, Phase I/II open-label trial of hydroxyurea designed to evaluate the feasibility, safety, long-term risks and benefits of hydroxyurea treatment for children with SCA in four sub-Saharan African countries (Mable Uganda,Kilifi Kenya, Luanda Angola and Kinshasa DRC).

He holds a Bachelor of Science in Computer Science from Gulu University, a post graduate diploma in Monitoring and Evaluation from Uganda Management Institute (UMI), Certificate in Project Management Professional from Devimpact Institute Kenya and various other certification in Clinical database development.

He Has 9 years of experience in Clinical Database design and Management, He is Currently overseeing data management work for the REACH study and all the day to day activities of the Project, He is also a member of the internal Clinical Trial Monitoring Unit and A chairperson Procurement Committee for Mbale Clinical Research Institute.

About

Ebitu Caleb Daniel serves as an I.T Support Officer at the Mbale Clinical Research Institute. He is recognized as an accomplished network and systems administrator, who takes pleasure in applying his skills to support and contribute to the technological advancement of research within the institution.
 
Ebitu graduated from Uganda Christian University Mukono with a Bachelor’s degree in Computer Science. Over the years, he has also acquired various certifications including CCNA, Information Security, Google Cloud Developer, PMP (Telecom), and Federated Identity Management.

About

Laban has accumulated over four years of experience in managing research financial processes since joining the Mbale Clinical Research Institute on July 1, 2019, as an Accounts Assistant. This experience complements his extensive background of over ten years in the banking sector, where he has previously worked for two banks in roles involving people management, cash management, internal controls, and accountability.

He holds a Bachelor’s degree in Business Studies, specializing in Accounting, from the Islamic University of Uganda. He is currently pursuing a Certificate of Public Accountants (CPA) from the Institute of Certified Public Accountants of Uganda (ICPAU), with only two papers remaining to complete the course.

Driven by an ambition to advance his career in accounting and expand his experience in research-related accounting managed by well-established systems and processes, he believes that MCRI is the ideal place for his professional growth.