Condition category
Infections and Infestations
Date applied
27/06/2008
Date assigned
18/09/2008
Last edited
18/09/2008
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

Mrs Elisabeth Andrade

ORCID ID

Contact details

Rua Padre Vieira
50/302
Minas Gerais
36025070
Brazil
+55 32 3232 2816
ecampos@terra.com.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised double blind controlled trial of nitazoxanide of the treatment in intestinal polyparasitism in humans

Acronym

Study hypothesis

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

The Committee of Ethics in Research in Human Beings of Propesq/UFJF, dated 15th March 2007 (ref: 063/2007)

Study design

Randomised double blind controlled trial, single centre

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Specified

Drug names

Nitazoxanide, secnidazole, albendazole

Primary outcome measures

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 trial start date

01/07/2008

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/07/2008

Recruitment end date

30/09/2008

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Padre Vieira, 50/302
Minas Gerais
36025070
Brazil

Sponsor information

Organisation

Federal University of Juiz de Fora (Brazil)

Sponsor details

Elisabeth Campos de Andrade
Rua Padre Vieira 50 /302
Minas Gerais
36025-070
Brazil

Sponsor type

University/education

Website

http://lattes.cnpq.br/0143686778100049

Funders

Funder type

University/education

Funder name

Federal University of Juiz de Fora (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Farmoquimica S/A (Brazil)

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

Publication citations

Additional files

Editorial Notes