Mebendazole compared with secnidazole-adult giardiasis-Phase III

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Efficacy and safety of mebendazole compared with secnidazole in the treatment of adult giardiasis: a randomised clinical trial

Source(s) of monetary or material support:

Central Military Hospital "Carlos J. Finlay"

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Pedro Almirall Carbonell

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

None

Research ethics committees:

Central Military Hospital "Carlos J. Finlay", March 25, 2006

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

04/05/2006

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Giardiasis

Intervention(s):

Group I (Experimental): Mebendazole 200 mg by oral route three times during three days, (64 patients). Group II (Control): Secnidazole 2g by oral route in a single dose, a single day, (62 patients).

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Parasitological answer (Cured: If no Giardia cysts or trophozoites be found in any of the three post-treatment faecal simples, Not cured: Other case (microscopical examination as direct wet mount and Ritchie concentration. Measuring time: 3, 5 and 7 days after treatment completion. Clinical answer (Without clinical manifestations, with a relieve of the clinical manifestations, with the same clinical manifestations). Measuring time: 12 days after treatment completion.

Key secondary outcomes:

Adverse Events (description of the events). Measuring time: 3 days after treatment completion. Intensity of AE (Slight, moderate or severe, taking into account the grade of disfunction produced by the event). Measuring time: 3 days after treatment completion.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

Informed-consent form signed. Patients with 18 years and older.

Exclusion criteria:

Patients who had previously received any antiparasitic drug within 1 month before entering the study. Have known about any hypersensitivity to any of the drugs in use. Have any immunodeficiency disease. Have any hepatic disease. Have any renal disease. Have any cardiovascular disease. Have any haematological disease. Have used other drugs joined to the drugs in use. Women were pregnant or lactation.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

110

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Pedro

Last Name:

Almirall Carbonell

Affiliation:

Faculty of Medical Sciences "Comandante Manuel Fajardo"

Postal Address:

Calle D entre Zapata y 29 (Vedado) Plaza.

City:

Havana city

País:

Cuba

Zip Code:

10400

Telephone:

53 7 8326550

Email :

almicar@infomed.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Pedro

Last Name:

Almirall Carbonell

Affiliation:

Faculty of Medical Sciences "Comandante Manuel Fajardo"

Postal Address:

Calle D entre Zapata y 29 (Vedado) Plaza.

City:

Havana city

País:

Cuba

Zip Code:

10400

Telephone:

53 7 8326550

Email :

almicar@infomed.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000095

Date of Registration in Primary Registry:

2010-04-21

Record Verification Date:

2010-03-30 20:00

Link to the spanish version:

Click here [3]