Common causes and patient outcomes of community-acquired pneumonia in sub-Saharan Africa
| ISRCTN | ISRCTN61173943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61173943 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Infectious Diseases Institute |
| Funder | European and Developing Countries Clinical Trials Partnership |
- Submission date
- 14/12/2021
- Registration date
- 31/01/2022
- Last edited
- 14/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Pneumonia is swelling (inflammation) of the tissue in one or both lungs. It's usually caused by a bacterial infection. Pneumonia is a common cause of death globally and requires appropriate antibiotic treatment. However most of the treatment for pneumonia remains empirical since the tests to establish the causes are not routinely done and these tests may not be able to detect the germs causing disease in a large percentage of patients with pneumonia. With widespread use of antibiotics for treating pneumonia, some of the germs causing pneumonia infection may be resistant to commonly used antibiotics and this may lead to poor treatment response among patients with pneumonia. This study uses novel tests for pneumonia to investigate whether they improve the diagnosis of pneumonia and help to identify germs that are resistant to usual antibiotics. Secondly, it investigates whether additional tests may help to identify patients with pneumonia who are at risk of poor response to treatment
Who can participate?
Adult patients diagnosed with pneumonia.
What does the study involve?
Patients will provide a sputum sample for analysis.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Infectious Disease Institute (Uganda)
When is the study starting and how long is it expected to run for?
February 2020 to September 2024
Who is funding the study?
European & Developing Countries Clinical Trials Partnership (EDCTP) (South Africa)
Who is the main contact?
Dr William Worodria, worodria@yahoo.com
Contact information
Scientific
Infectious Diseases Institute
P.O. Box 22418
Kampala
-
Uganda
 ORCID ID |
0000-0002-8531-5567 |
|---|---|
| Phone | +256 772424601 |
| wworodria@idi.co.ug |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational single centre cohort study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Management of Lower Respiratory Tract Infections in Sub-Saharan Africa, a pragmatic approach |
| Study acronym | LoRTISA |
| Study objectives | 1. Adding nucleic acid testing for viruses and other hard to detect pathogens will improve microbiological identification of pathogens by at least 33% 2. Blood biomarkers like CRP and PCT may be useful clinically and help to identify individuals with pneumonia at risk of early treatment failure. |
| Ethics approval(s) | Approved 17/11/2020, Makerere College of Health Sciences, School of Medicine, Research Ethics Committee (PO Box 7072, Kampala, Uganda; +256 414533541; ponsiano.ocama@gmail.com), ref: 2020-204 |
| Health condition(s) or problem(s) studied | Community acquired pneumonia |
| Intervention | Patients hospitalized with community acquired pneumonia will have their sputum tested using conventional culture based tests and this will be compared with multiplex PCR tests to determine the performance of these novel molecular diagnostic tests for pneumonia. Clinical biomarkers (C-reactive pneumonia and procalcitonin) will also be used to assess the prognosis of patients with pneumonia. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Diagnostic test (Biofire FilArray) compared with the gold standard at study enrollment |
| Key secondary outcome measure(s) |
Biomarkers (CRP, PCT) compared against Early Treatment failure at day 3 using sputum test |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 406 |
| Key inclusion criteria | 1. Clinically diagnosed pneumonia (fever ≥38°C, with cough, chest pain, breathlessness or hemoptysis) and at least one focal chest sign (crepitations, pleural rub, bronchial breathing, dullness on percussion or diminished breath sounds) for <3 weeks 2. Consent to study participation |
| Key exclusion criteria | 1. Hospitalized in the last 30 days 2. Cancer chemotherapy 3. Have chronic renal failure 4. Treatment for active pulmonary tuberculosis 5. Respiratory failure secondary to severe chronic obstructive lung disease 6. Congestive heart failure |
| Date of first enrolment | 18/01/2022 |
| Date of final enrolment | 30/08/2024 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Kampala
-
Uganda
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
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
14/10/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 30/08/2024.
2. The overall end date was changed from 31/12/2023 to 30/09/2024.
3. The plain English summary was updated to reflect these changes.
18/01/2022: Trial's existence confirmed by Makerere University
