Comparison of three diagnostic methods to assess albendazole efficacy

ISRCTN ISRCTN90088840
DOI https://doi.org/10.1186/ISRCTN90088840
Secondary identifying numbers N/A
Submission date
21/09/2009
Registration date
01/10/2009
Last edited
06/06/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marco Albonico
Scientific

Department of Biology
Faculty of Science
Torino
10122
Italy

Phone +39 011 431 0218
Email albonico@tin.it

Study information

Study designObservational cross-sectional parasitological survey
Primary study designObservational
Secondary study designCross-section survey
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleComparison of three diagnostic methods to assess albendazole efficacy: a cross-sectional parasitological survey
Study acronymKato-FLOTAC-McMaster
Study objectivesA single FLOTAC® test is more sensitive than a single Kato-Katz thick smear or a single McMaster test for the diagnosis of soil-transmitted helminth infections.
Ethics approval(s)Ethikkommission beider Basel (EKBB), 14/09/2009, ref: 278/09
Health condition(s) or problem(s) studiedSoil-transmitted helminthiasis (ascariasis, hookworm disease, trichuriasis)
InterventionEach day, a total of 20 children will be enrolled. They are invited to provide a single stool sample that will be subjected to three different diagnostic methods. After stool collection, each child will be treated with a single 400 mg oral dose of albendazole (regardless of the parasitological findings). The next day, another 20 children will be enrolled, following the same procedures. After 21 days (15 working days, 5 days per week), the first roster of 20 children will be re-examined and a second stool sample will be collected from the same 20 children. The baseline and the follow-up surveys will therefore take each 3 weeks.

The total duration of the trial is 6 weeks. We put down 3 months to have some safety margin. Based on the above, please note that there is only one intervention arm; each child will be administered albendazole (400 mg).
Intervention typeOther
Primary outcome measureSensitivity of diagnost test, measured at three weeks post-treatment follow-up
Secondary outcome measuresMeasured at three weeks post-treatment follow-up:
1. Agreement between diagnostic tests for prevalence and infection intensity estimates
2. Negative predictive value
Overall study start date27/09/2009
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants300
Key inclusion criteria1. Child judged healthy by study physician
2. Written informed consent provided by child's parent or guardian
3. Provision of stool sample
4. No recent history of anthelminthic treatment (drugs administered within the past 2 weeks)
5. School-aged children between 5 and 16 years (although in some cases this can go as high as 20 years), either sex
Key exclusion criteria1. Too sick to attend school or participate in the study (e.g. severe diarrhoea, severe anaemia, high fever, etc.)
2. No parental/guardian's permission to participate (absence of written informed consent)
3. Do not provide a stool sample
4. Recent history of anthelminthic treatment (drugs administered within the past 2 weeks)
Date of first enrolment27/09/2009
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Italy
  • Tanzania

Study participating centre

Department of Biology
Torino
10122
Italy

Sponsor information

Ivo de Carneri Foundation (Italy)
Research organisation

Department of Biology
Faculty of Science
Torino
10122
Italy

Phone +39 011 431 0218
Email albonico@tin.it
Website http://www.fondazionedecarneri.it/en/

Funders

Funder type

Research organisation

Ivo de Carneri Foundation (Italy)

No information available

University of Naples Federico II (Italy) - Department of Pathology and Animal Health, Faculty of Veterinary Medicine

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2013 Yes No