The burden of serious fungal diseases in Uganda

ISRCTN	ISRCTN10570729
DOI	https://doi.org/10.1186/ISRCTN10570729
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	2021-000459-38
Protocol serial number	1
Sponsor	Makerere University
Funder	European and Developing Countries Clinical Trials Partnership

Submission date: 27/01/2021
Registration date: 05/02/2021
Last edited: 05/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Information is limited on the magnitude of the burden of serious fungal diseases in Uganda. Serious fungal diseases that can potentially lead to death include infections in the blood or internal organs. This study investigates blood fungal diseases and mycetoma, which commonly affects the foot. The study aims to describe the number of people with the disease, risk factors for acquiring the disease and environmental sources (if any) of the fungi causing the disease. Additionally, the study will be focused on determining the environmental sources of Cryptococcus, which causes disease in the blood.

Who can participate?
Two categories of people can participate in the study:
1. Sick people who have signs of blood fungal infection, including fever for a long time which fails to respond to the common antibiotics, having high breathing and heart rates and low blood pressure when brought to the hospital
2. People who have a large, non-painful swelling, commonly on the foot, which is draining some fluids and perhaps some grains

What does the study involve?
The study involves three activities:
1. Collection of blood from sick people to study the number and risk factors and the type of medicine for people with fungi.
2. Collection of muscle tissue from patients with mycetoma of the foot to study the fungi causing it.
3. Collection of samples from the environment- such as tree barks to determine the environmental sources of Cryptococcus species.

What are the possible benefits and risks of participating?
Possible benefits include a guided treatment plan which includes timely laboratory results and information on incidental findings. Risk factors include the patients becoming anaemic from loss of blood (8-10 ml) which is significant in critically ill patients. However, the likelihood of a positive blood culture increases with a higher blood volume. Blood draws will be made in consultation with the attending clinicians at the study sites. Other risk factors include secondary wound infection during sample collection for the study of mycetoma. Patients who get secondary bacterial infections will be supported to access the standard of care.

Where is the study run from?
Makerere University (Uganda)

When is the study starting and how long is it expected to run for?
November 2019 to October 2022

Who is funding the study?
The European and Developing Countries Clinical Trials Partnership (Netherlands)

Who is the main contact?
Dr Beatrice Achan
bachan@chs.mak.ac.ug

Contact information

Dr Beatrice Achan
Scientific

Department of Medical Microbiology
Room C22
Upper Mulago Hill Road
Kampala, Uganda
Kampala
-
Uganda

ORCID ID	0000-0001-9741-5429
Phone	+256 (0)784 260 263
Email	bachan@chs.mak.ac.ug

Mr Joseph Odokonyero Odokonyero
Public

Mycobacteriology Laboratory
Kampala
+256
Uganda

ORCID ID	0000-0001-9741-5429
Phone	+256 (0)782 593 959
Email	odokonyero.joseph@chs.mak.ac.ug

Study information

Primary study design	Observational
Study design	Descriptive cross-sectional study
Secondary study design	Cross sectional study
Study type	Participant information sheet
Scientific title	The epidemiology of invasive fungal diseases in Uganda
Study acronym	Fungal-UG
Study objectives	There is limited information on the epidemiology of invasive fungal diseases in Uganda. Therefore, the study aims to describe the epidemiology of invasive fungal diseases in Uganda.
Ethics approval(s)	1. Approved 23/07/2020, Makerere University School of Biomedical Sciences Research and Ethics Committee (PO Box 7072 Kampala, Uganda; +256 (0)752 575 050; biomedicalresearch62@gmail.com), ref: SBS639 2. Approved 23/03/2020, Uganda National Council for Science and Technology (Uganda National Council for Science and Technology, PO Box 6884, Kampala, Uganda; +256 (0)414 705 500; info@uncst.go.ug), ref: HS2610
Health condition(s) or problem(s) studied	Fungal bloodstream infections, mycetoma
Intervention	Blood culture retrieved fungi will be identified to the species level by a phenotypic algorithm for identification; the India ink, Germ tube test, use of 10% KOH, culture on/in identification media and EUCASt method will be used for antifungal susceptibility testing.
Intervention type	Other
Primary outcome measure(s)	1. The number of patients with fungal bloodstream infections measured using blood culture specimens collected at baseline (enrolment) 2. The number of patients with mycetoma measured by histopathological stains on biopsy specimens collected at baseline (enrolment) 3. The environmental distribution of Cryptococcus species causing cryptococcal meningitis using PCR of environmental samples at baseline
Key secondary outcome measure(s)	1. Species of fungal pathogens isolated, identified using the conventional phenotypic algorithm for identification after blood culture at 7 days 2. Antifungal resistance profile of fungal pathogens isolated, measured using EUCAST method at 48 h per protocol 3. Molecular ecology of Cryptococcus measured using PCR assay at 48 h
Completion date	31/10/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	562
Key inclusion criteria	1. Adults aged >18 years with features of sepsis: temperature >38, tachycardia, tachypnoea, suspected focus of infection 2. Adults aged >18 years with features of mycetoma: painless subcutaneous mass, multiple sinuses, discharge
Key exclusion criteria	Patients who do not provide informed consent
Date of first enrolment	01/03/2020
Date of final enrolment	01/07/2022

Locations

Countries of recruitment

Uganda

Study participating centres

Mulago National Referral Hospital

Kampala
-
Uganda

Lacor Hospital

Gulu
-
Uganda

Lira Regional Referral Hospital

Lira
-
Uganda

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a publicly available online repository called Fungal-UG database that will be made available at manuscript submission for 1 year. The information will be open access for sharing with the global community. Consent for further research is included in the consent forms, approved by the ethical review committees. All data will be anonymised using only study identification numbers. The database is currently not yet online for purposes of protecting the data set before publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/02/2021: Trial's existence confirmed by Mulago National Referral Hospital.