Effect of malaria prevention on in-hospital mortality among severely ill tuberculosis patients

ISRCTN	ISRCTN83944306
DOI	https://doi.org/10.1186/ISRCTN83944306
Secondary identifying numbers	N/A

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

Via Giustiniani 2
Padova
35100
Italy

Phone	+39 345 535 6570
Email	rcolombatti@gmail.com

Study information

Study design	Single centre non-randomised trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/01/2005
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	900 - 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

Sponsor information

Aid, Health and Development (AHEAD) - Onlus (Italy)
Research organisation

c/o Fabio Riccardi
Via San Damaso 15
Rome
00165
Italy

Website	http://www.ahead-onlus.org
"ROR"	https://ror.org/00d0m6v41

Funders

Funder type

Charity

The Global Fund to Fight AIDS, Tuberculosis and Malaria (Switzerland)

No information available

US Agency for International Development (USAID) (USA)

No information available

Aid, Health and Development (AHEAD) - Onlus (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan