Treatment of Asymptomatic Toxocariasis With Albendazole i... | NCT00755560

Studies
Treatment of Asymptomatic Toxocariasis With Albendazole in Children

NCT00755560

Sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Status

Unknown status

Last Update Posted

Mar 2, 2023Actual

Enrollment

45Actual

Phase

Phase 3

Conditions

Toxocariasis

Interventions

Albendazole
Placebo

Countries

Argentina

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 2023

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

Sep 2008

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2025Estimated

First Submitted Date

Sep 17, 2008

First Submission Date that Met QC Criteria

Sep 18, 2008

First Posted Date

Sep 19, 2008Estimated

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 28, 2023

Last Update Posted Date

Mar 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Jaime Altcheh, Service Head, Parasitology and Chagas Service, Hospital de Niños R. Gutierrez de Buenos AiresPrincipal Investigator

Lead Sponsor

Hospital de Niños R. Gutierrez de Buenos AiresOTHER

Collaborators

Not provided

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 purpose of this study is to evaluate effectiveness of albendazole in the treatment of the asymptomatic infection with the parasite Toxocara in children. Treatment response is defined as a reduction in the number of eosinophils in blood. The study drug will be compared to placebo and randomly assigned in a double blind manner. Follow up will be prospective. 50 children (25 per group) will be enrolled in the study.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Albendazole	Active Comparator	Albendazole 10 - 15 mg/kg/day BID for 15 days	Drug: Albendazole
Placebo	Placebo Comparator	Placebo BID for 15 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Albendazole	Drug	Albendazole 10 - 15 mg/kg/day BID for 15 days	Albendazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean absolute reduction in eosinophil count from baseline		12 months after treatment

Secondary Outcomes

Measure	Description	Time Frame
Reduction in eosinophil count in more than 60% from baseline		1 year
Incidence of adverse drug events		3, 6, 9 and 12 months after treatment
Mean absolute reduction in eosinophil count

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric ambulatory patients with asymptomatic toxocariasis
Children 2 - 15 years old
Absolute eosinophil count > 1100 / mm3
Normal ophthalmoscopy

Exclusion Criteria:

Treatment with a benzimidazole in the previous year
Infection by other nematodes (Ascaris lumbricoides, strongyloides stercoralis, uncinarias, Trichuris trichuria)
Symptomatic patients (prolonged fever, acute pneumonitis, hepatomegaly, splenomegaly, ocular compromise due to toxocara)
Concomitant diseases
Immunocompromised patients
Altered liver or kidney function
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaime Altcheh, MD	Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires	Study Chair
Hector Freilij, MD	Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires		Buenos Aires		1425	Argentina

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014120	Toxocariasis
D004802	Eosinophilia

Ancestor Terms

ID	Term
D006374	Helminthiasis, Animal
D006373	Helminthiasis
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015766	Albendazole

Ancestor Terms

ID	Term
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided