NCT00849602

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

Enrollment Period

3 months

First QC Date

February 23, 2009

Last Update Submit

February 23, 2009

Conditions

Dengue

Outcome Measures

Primary Outcomes (1)

  • Duration of the disease

    one week

Secondary Outcomes (1)

  • Intensity and days of fever and symptoms

    one week

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: Placebo

2

ACTIVE COMPARATOR
Drug: Chloroquine

Interventions

PlaceboDRUG

Placebo bid for three days

1
ChloroquineDRUG

Chloroquine bid for three days

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant
  • Younger than 18-years old
  • Either cardiac or neurologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

São Paulo University Medical School at Ribeirão Preto

Ribeirão Preto, São Paulo, 14048.900, Brazil

Location

MeSH Terms

Conditions

Dengue

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Benedito AL Fonseca, PhD

    São Paulo University Medical School at Ribeirão Preto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 24, 2009

Study Start

February 1, 2008

Primary Completion

May 1, 2008

Study Completion

June 1, 2009

Last Updated

February 24, 2009

Record last verified: 2009-02

Locations

BR(1)