Addressing the challenges associated with neglected infectious diseases in at-risk individuals
| ISRCTN | ISRCTN33572982 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33572982 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | TMA2019CDF-2789-MeMoF |
| Sponsor | Mbarara University of Science and Technology |
| Funder | European and Developing Countries Clinical Trials Partnership |
- Submission date
- 06/09/2021
- Registration date
- 17/11/2021
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
This study seeks to establish the relevance of opportunistic fungal co-infections with the specific aims of:
1. Determining the burden of fungal co-infections among patients with chronic pulmonary (lung) disease suspected of tuberculosis (TB)
2. To establish and characterise microbial communities associated with chronic pulmonary disease
3. To characterise potential interactions between fungal and bacterial communities
Who can participate?
Patients aged 18 and over with a productive cough presenting with TB-like symptoms
What does the study involve?
Three sputum samples will be collected from each participant with a space of 3-4 days for analysis of the incidence of pulmonary fungal infections.
What are the possible benefits and risks of participating?
Possible benefits include improved diagnosis and management of patients. No risks are foreseen.
Where is the study run from?
Mbarara University Teaching Hospital (Uganda)
When is the study starting and how long is it expected to run for?
October 2020 to September 2024
Who is funding the study?
European & Developing Countries Clinical Trials Partnership (Netherlands)
Who is the main contact?
Dr Herbert Itabangi
hitabangi@must.ac.ug
Contact information
Public
PO Box 1410
Mbarara
256
Uganda
 ORCID ID |
0000-0003-3010-2537 |
|---|---|
| Phone | +256 (0)775554564 |
| hitabangi@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Laboratory-based cross-sectional study |
| Secondary study design | Cross sectional study |
| Participant information sheet | 40377_PIS.pdf |
| Scientific title | Metabolic and molecular ecological evolution of opportunistic pulmonary fungal co-infections |
| Study acronym | MUREC-1/7 |
| Study objectives | 1. The burden of opportunistic pulmonary fungal co-infections is higher than culture-dependent data suggests 2. Culture-independent data complements culture-dependent data in supporting therapeutic decisions 3. Fungal-bacterial co-existence influences fungal virulence |
| Ethics approval(s) | Approved 07/10/2020, Mbarara University of Science and Technology Research Ethics Committee (PO Box 1410, Mbarara, Uganda; +256 (0)485433795; sec.rec@must.ac.ug, irc@must.ac.ug), ref: MUREC1/7 |
| Health condition(s) or problem(s) studied | Pulmonary fungal co-infections in patients with TB-like symptoms |
| Intervention | Participants earmarked for the study will be consented to, instructed and guided on the sputum sample collection. Up to three samples will be collected from each participant with a space of 3-4 days. Following collection, the samples will be examined for some preliminary results that can be used in the management of participants. Following complete sample collection, the participants will not be required again and thus no follow up will be required. |
| Intervention type | Other |
| Primary outcome measure(s) |
Incidence of pulmonary fungal infections measured using Prevalence Index at baseline and 18, 30 and 36 months |
| Key secondary outcome measure(s) |
Clinical management measured using a diagnostic approach at baseline and 36 months |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 480 |
| Key inclusion criteria | 1. HIV/AIDS patients suspected of TB 2. Presenting with TB-like symptoms including a chronic cough that has persisted for more than 3 months 3. Aged 18 years and above 4. TB naive 5. Give consent |
| Key exclusion criteria | 1. Critically ill patients, who would delay recruitment due to associated delays in sample collection and consent 2. Diabetics and pregnant women suspected of TB are managed differently according to TB guidelines 3. HIV/AIDs patients with TB-like symptoms but on anti-TB treatment 4. Patients with a known diagnosis |
| Date of first enrolment | 10/10/2021 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- Uganda
Study participating centres
Mbarara
256
Uganda
Mbale
256
Uganda
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Herbert Itabangi (hitabangi@gmail.com/hitabanngi@must.ac.ug). Data will be shared as required by the WHO and ICMJE. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 15/08/2023 | 16/08/2023 | Yes | No | |
| Participant information sheet | 09/09/2021 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Preprint results | 05/12/2023 | 25/11/2024 | No | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 40377_PIS.pdf
- Participant information sheet
Editorial Notes
20/01/2025: The sponsor details were changed
25/11/2024: Publication reference added.
25/09/2023: The acronym was changed from MeMoF to MUREC-1/7.
16/08/2023: Publication reference added.
10/01/2022: Internal review.
09/09/2021: Trial's existence confirmed by the European and Developing Countries Clinical Trials Partnership.
