Condition category
Infections and Infestations
Date applied
05/09/2010
Date assigned
27/09/2010
Last edited
27/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 physician’s 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

http://www.ahead-onlus.org

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

Publication citations

Additional files

Editorial Notes