The Effect of Chloroquine in the Treatment of Patients Wi... | NCT00849602

Studies
The Effect of Chloroquine in the Treatment of Patients With Dengue

NCT00849602

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Feb 24, 2009Estimated

Enrollment

132Estimated

Phase

Phase 1Phase 2

Conditions

Dengue

Interventions

Placebo
Chloroquine

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

May 2008Estimated

Completion Date

Jun 2009Estimated

First Submitted Date

Feb 23, 2009

First Submission Date that Met QC Criteria

Feb 23, 2009

First Posted Date

Feb 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2009

Last Update Posted Date

Feb 24, 2009Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Drug: Placebo
2	Active Comparator		Drug: Chloroquine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo bid for three days	1
Chloroquine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of the disease		one week

Secondary Outcomes

Measure	Description	Time Frame
Intensity and days of fever and symptoms		one week

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benedito AL Fonseca, PhD	São Paulo University Medical School at Ribeirão Preto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
São Paulo University Medical School at Ribeirão Preto		Ribeirão Preto	São Paulo	14048.900	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003715	Dengue

Ancestor Terms

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002738	Chloroquine

Ancestor Terms

ID	Term
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided