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 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
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
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
-
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.