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 designSingle centre non-randomised trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffect of malaria prevention on in-hospital mortality among severely ill tuberculosis patients: a single centre non-randomised trial
Study acronymTBMPrev
Study objectivesTo 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) studiedMalaria/tuberculosis
Intervention1. 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 typeOther
Primary outcome measureDeath or discharge from hospital
Secondary outcome measures1. Drop-outs (defined as voluntary discharge from hospital before recovery against physician’s advice and/or treatment abandonment)
2. Percentage of attendance of health education classes
Overall study start date01/01/2005
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants900 - 1000
Key inclusion criteriaAll patients (aged 0 - 75 years, either sex) admitted to the National Reference Hospital for Tuberculosis and Lung Diseases, Hospital "Raoul Follereau"
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/01/2005
Date of final enrolment31/12/2007

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan