Comparison of three diagnostic methods to assess albendazole efficacy
| ISRCTN | ISRCTN90088840 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90088840 |
| Protocol serial number | N/A |
| Sponsor | Ivo de Carneri Foundation (Italy) |
| Funders | Ivo de Carneri Foundation (Italy), University of Naples Federico II (Italy) - Department of Pathology and Animal Health, Faculty of Veterinary Medicine |
- 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
Scientific
Department of Biology
Faculty of Science
Torino
10122
Italy
| Phone | +39 011 431 0218 |
|---|---|
| albonico@tin.it |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross-sectional parasitological survey |
| Secondary study design | Cross-section survey |
| Study type | Participant information sheet |
| Scientific title | Comparison of three diagnostic methods to assess albendazole efficacy: a cross-sectional parasitological survey |
| Study acronym | Kato-FLOTAC-McMaster |
| Study objectives | 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(s) | Ethikkommission beider Basel (EKBB), 14/09/2009, ref: 278/09 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Sensitivity of diagnost test, measured at three weeks post-treatment follow-up |
| Key secondary outcome measure(s) |
Measured at three weeks post-treatment follow-up: |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 300 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 27/09/2009 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Italy
- Tanzania
Study participating centre
Department of Biology
Torino
10122
Italy
10122
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
