A randomised double blind controlled trial of nitazoxanide in intestinal polyparasitism in humans: a Brazilian study
| ISRCTN | ISRCTN74820169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74820169 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/06/2008
- Registration date
- 18/09/2008
- Last edited
- 18/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Elisabeth Andrade
Scientific
Scientific
Rua Padre Vieira, 50/302
Minas Gerais
36025070
Brazil
| Phone | +55 32 3232 2816 |
|---|---|
| ecampos@terra.com.br |
Study information
| Study design | Randomised double blind controlled trial, single centre |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised double blind controlled trial of nitazoxanide of the treatment in intestinal polyparasitism in humans |
| Study objectives | Nitazoxanide is a drug with an ample spectrum of activity, a superior or equivalent effectiveness to secnidazole and/or albendazole in the treatment of majority of intestinal parasitism in humans, and presents with less adverse effects than the previously cited drugs. |
| Ethics approval(s) | The Committee of Ethics in Research in Human Beings of Propesq/UFJF, dated 15th March 2007 (ref: 063/2007) |
| Health condition(s) or problem(s) studied | Intestinal polyparasitism |
| Intervention | 1. Nitazoxanide = 15 mg/kg/day every 12 hours for children, 500 mg tablet every 12 hours for adults, during three days 2. Secnidazole = 30 mg/kg/day for children and 2 g for adults in one dose 3. Albendazole = 400 mg in one dose (suspension for 400 mg for children, tablets of 400 mg for adults) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nitazoxanide, secnidazole, albendazole |
| Primary outcome measure | 1. Cure (non-infected) defined as an absence of any species of parasite in the examination of excrements 2. Cure absence (infected) defined as maintenance of the pre-existing parasite These outcomes will be measured in July and September 2008. |
| Secondary outcome measures | Prevalence of adverse effects. These outcomes will be measured in July and September 2008. |
| Overall study start date | 01/07/2008 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Participants more than one year of age, either sex 2. Positive for one or more species of intestinal parasites 3. Rural populations in the Zona da Mata of the State of Minas Gerais (Brazil) 4. Taken care of by the Unified National Health System (SUS) |
| Key exclusion criteria | 1. Intestinal obstruction for intestinal parasitisms 2. Pregnant 3. Patients with liver or renal insufficiency 4. Alterations in biliary treatment 5. Patient is using warfarin, aspirin, phenytoin, carbamazepine or valproic acid |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Padre Vieira, 50/302
Minas Gerais
36025070
Brazil
36025070
Brazil
Sponsor information
Federal University of Juiz de Fora (Brazil)
University/education
University/education
Elisabeth Campos de Andrade
Rua Padre Vieira 50 /302
Minas Gerais
36025-070
Brazil
| Website | http://lattes.cnpq.br/0143686778100049 |
|---|---|
"ROR" |
https://ror.org/04yqw9c44 |
Funders
Funder type
University/education
Federal University of Juiz de Fora (Brazil)
No information available
Farmoquimica S/A (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
