The burden of serious fungal diseases in Uganda
| ISRCTN | ISRCTN10570729 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10570729 |
| EudraCT/CTIS number | 2021-000459-38 |
| Secondary identifying numbers | 1 |
- 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
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
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 |
| bachan@chs.mak.ac.ug |
Public
Mycobacteriology Laboratory
Kampala
+256
Uganda
| ORCID ID |
0000-0001-9741-5429 |
|---|---|
| Phone | +256 (0)782 593 959 |
| odokonyero.joseph@chs.mak.ac.ug |
Study information
| Study design | Descriptive cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | https://www.fungal-ug.com/ |
| 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/11/2019 |
| Completion date | 31/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | N = 385 with sepsis, N= 177 with mycetoma |
| 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
-
Uganda
-
Uganda
-
Uganda
Sponsor information
University/education
College of Health Sciences
PO Box 7072
Kampala
-
Uganda
| Phone | +256 (0)784 260 262 |
|---|---|
| principal@chs.mak.ac.ug | |
| Website | https://chs.mak.ac.ug/content/epidemiology-invasive-fungal-diseases-uganda |
"ROR" |
https://ror.org/03dmz0111 |
Funders
Funder type
Research organisation
Private sector organisation / International organizations
- Alternative name(s)
- Le partenariat Europe-Pays en développement pour les essais cliniques, A Parceria entre a Europa e os Países em Desenvolvimento para a Realização de Ensaios Clínicos, The European & Developing Countries Clinical Trials Partnership, European and Developing Countries Clinical Trials, EDCTP
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in open access peer-reviewed journals. |
| 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. |
Editorial Notes
01/02/2021: Trial's existence confirmed by Mulago National Referral Hospital.
