Back to resultsThe Effect of Chloroquine in the Treatment of Patients With Dengue
Primary Purpose
Dengue
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Placebo
Chloroquine
Sponsored by
About this trial
This is an interventional treatment trial for Dengue
Eligibility Criteria
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
Sites / Locations
- São Paulo University Medical School at Ribeirão Preto
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Duration of the disease
Secondary Outcome Measures
Intensity and days of fever and symptoms
Full Information
NCT ID
NCT00849602
First Posted
February 23, 2009
Last Updated
February 23, 2009
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00849602
Brief Title
The Effect of Chloroquine in the Treatment of Patients With Dengue
Official Title
The Effect of Chloroquine in the Treatment of Patients With Dengue
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2008 (Anticipated)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study was to evaluate the effect of chloroquine in the treatment of patients with dengue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo bid for three days
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Intervention Description
Chloroquine bid for three days
Primary Outcome Measure Information:
Title
Duration of the disease
Time Frame
one week
Secondary Outcome Measure Information:
Title
Intensity and days of fever and symptoms
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedito AL Fonseca, PhD
Organizational Affiliation
São Paulo University Medical School at Ribeirão Preto
Official's Role
Principal Investigator
Facility Information:
Facility Name
São Paulo University Medical School at Ribeirão Preto
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14048.900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
The Effect of Chloroquine in the Treatment of Patients With Dengue
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