The Effect of Chloroquine in the Treatment of Patients With Dengue

Dengue Clinical Trial

Official title:

The Effect of Chloroquine in the Treatment of Patients With Dengue

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00849602
• Other study ID #: BALF-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 23, 2009
• Last updated: February 23, 2009
• Start date: February 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to evaluate the effect of chloroquine in the treatment of patients with dengue.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: June 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients suspected of having dengue disease

• Patients were included in the study if they presented with fever and at least two other symptoms, such as:

• headache

• pain behind the eyes

• muscle and bone or joint pains

• nausea

• vomiting

• rash associated to dengue for less than 72 hours

Exclusion Criteria:

• Pregnant

• Younger than 18-years old

• Either cardiac or neurologic disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dengue

Intervention

Drug:
• Placebo
Placebo bid for three days
• Chloroquine
Chloroquine bid for three days

Locations

Country	Name	City	State
Brazil	São Paulo University Medical School at Ribeirão Preto	Ribeirão Preto	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the disease		one week	Yes
Secondary	Intensity and days of fever and symptoms		one week	Yes