Contact information
Type
Scientific
Primary contact
Dr Raffaella Colombatti
ORCID ID
Contact details
Via Giustiniani 2
Padova
35100
Italy
+39 345 535 6570
rcolombatti@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of malaria prevention on in-hospital mortality among severely ill tuberculosis patients: a single centre non-randomised trial
Acronym
TBMPrev
Study hypothesis
To reduce mortality in admitted tuberculosis (TB) patients during the rainy season through a three-step malaria prevention program.
Ethics approval
Local Ethics Committee (Ethics Committee of Hospital Raoul Follereau) approved in December 2004.
Study design
Single centre non-randomised trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Death or discharge from hospital
Secondary outcome measures
1. Drop-outs (defined as voluntary discharge from hospital before recovery against physicians advice and/or treatment abandonment)
2. Percentage of attendance of health education classes
Overall trial start date
01/01/2005
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
All patients (aged 0 - 75 years, either sex) admitted to the National Reference Hospital for Tuberculosis and Lung Diseases, Hospital "Raoul Follereau"
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
900 - 1000
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2005
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Guinea-Bissau
Trial participating centre
Via Giustiniani 2
Padova
35100
Italy
Sponsor information
Organisation
Aid, Health and Development (AHEAD) - Onlus (Italy)
Sponsor details
c/o Fabio Riccardi
Via San Damaso 15
Rome
00165
Italy
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
The Global Fund to Fight AIDS, Tuberculosis and Malaria (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
US Agency for International Development (USAID) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Aid, Health and Development (AHEAD) - Onlus (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary