Effect of malaria prevention on in-hospital mortality among severely ill tuberculosis patients
| ISRCTN | ISRCTN83944306 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83944306 |
| Protocol serial number | N/A |
| Sponsor | Aid, Health and Development (AHEAD) - Onlus (Italy) |
| Funders | The Global Fund to Fight AIDS, Tuberculosis and Malaria (Switzerland), US Agency for International Development (USAID) (USA), Aid, Health and Development (AHEAD) - Onlus (Italy) |
- Submission date
- 05/09/2010
- Registration date
- 27/09/2010
- Last edited
- 27/09/2010
- 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
Not provided at time of registration
Contact information
Dr Raffaella Colombatti
Scientific
Scientific
Via Giustiniani 2
Padova
35100
Italy
| Phone | +39 345 535 6570 |
|---|---|
| rcolombatti@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre non-randomised trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of malaria prevention on in-hospital mortality among severely ill tuberculosis patients: a single centre non-randomised trial |
| Study acronym | TBMPrev |
| Study objectives | To reduce mortality in admitted tuberculosis (TB) patients during the rainy season through a three-step malaria prevention program. |
| Ethics approval(s) | Local Ethics Committee (Ethics Committee of Hospital Raoul Follereau) approved in December 2004. |
| Health condition(s) or problem(s) studied | Malaria/tuberculosis |
| Intervention | 1. A permethrin-treated bednet will be given to every patient upon admission since 2005 and during all the three years of the intervention; bednets will be retreated every 30 - 45 days. 2. Environmental disinfection will be performed monthly with permethrin-based products by appropriately trained hospital staff according to manufactor's instructions during the rainy season of 2006 and 2007; spraying will be conducted both outdoor (with Microsin) and indoor (with Petrin L) on doors and window frames. 3. Prophylaxis with once daily trimethoprim 80 mg/sulfamethoxazole 400 mg tablet will be given to every patient admitted from July 1st to October 30th only in 2007 Treatment will be given for free to all patients and health education classes on malaria prevention have been given since 2005. |
| Intervention type | Other |
| Primary outcome measure(s) |
Death or discharge from hospital |
| Key secondary outcome measure(s) |
1. Drop-outs (defined as voluntary discharge from hospital before recovery against physicians advice and/or treatment abandonment) |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 1000 |
| Key inclusion criteria | All patients (aged 0 - 75 years, either sex) admitted to the National Reference Hospital for Tuberculosis and Lung Diseases, Hospital "Raoul Follereau" |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Guinea-Bissau
- Italy
Study participating centre
Via Giustiniani 2
Padova
35100
Italy
35100
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
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 |
