Condition category
Infections and Infestations
Date applied
21/09/2009
Date assigned
01/10/2009
Last edited
06/06/2014
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 Marco Albonico

ORCID ID

Contact details

Department of Biology
Faculty of Science
Torino
10122
Italy
+39 011 431 0218
albonico@tin.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of three diagnostic methods to assess albendazole efficacy: a cross-sectional parasitological survey

Acronym

Kato-FLOTAC-McMaster

Study hypothesis

A single FLOTACĀ® 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

Ethikkommission beider Basel (EKBB), 14/09/2009, ref: 278/09

Study design

Observational cross-sectional parasitological survey

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Soil-transmitted helminthiasis (ascariasis, hookworm disease, trichuriasis)

Intervention

Each 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Sensitivity of diagnost test, measured at three weeks post-treatment follow-up

Secondary outcome measures

Measured at three weeks post-treatment follow-up:
1. Agreement between diagnostic tests for prevalence and infection intensity estimates
2. Negative predictive value

Overall trial start date

27/09/2009

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. 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)

Recruitment start date

27/09/2009

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Tanzania

Trial participating centre

Department of Biology
Torino
10122
Italy

Sponsor information

Organisation

Ivo de Carneri Foundation (Italy)

Sponsor details

Department of Biology
Faculty of Science
Torino
10122
Italy
+39 011 431 0218
albonico@tin.it

Sponsor type

Research organisation

Website

http://www.fondazionedecarneri.it/en/

Funders

Funder type

Research organisation

Funder name

Ivo de Carneri Foundation (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23843559

Publication citations

  1. Results

    Albonico M, Rinaldi L, Sciascia S, Morgoglione ME, Piemonte M, Maurelli MP, Musella V, Utzinger J, Ali SM, Ame SM, Cringoli G, Comparison of three copromicroscopic methods to assess albendazole efficacy against soil-transmitted helminth infections in school-aged children on Pemba Island., Trans. R. Soc. Trop. Med. Hyg., 2013, 107, 8, 493-501, doi: 10.1093/trstmh/trt051.

Additional files

Editorial Notes