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Active, not recruitingNCT00755560Updated Mar 2, 2023

Treatment of Asymptomatic Toxocariasis With Albendazole in Children

A Phase 3 interventional study of Albendazole and Placebo in Toxocariasis, sponsored by Hospital de Niños R. Gutierrez de Buenos Aires. Active, not recruiting at 1 site in Argentina. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2023-03-02.

Sponsored by Hospital de Niños R. Gutierrez de Buenos Aires · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
2 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Toxocariasis

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Keywords

  • Toxocara
  • Pediatrics
  • Albendazole
  • eosinophilia
  • parasitology
  • pediatric clinical pharmacology
03

In context

Eosinophilia

52 studies on the registry are indexed under Eosinophilia; 9 are open to participants now.

This study's enrollment of 45 is close to the median of 48 across 32 interventional studies indexed under Eosinophilia.

Browse Eosinophilia studies →

Lead sponsor

Hospital de Niños R. Gutierrez de Buenos Aires is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
  • patients
  • Altered liver or kidney function
  • Pregnancy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Albendazole

    Albendazole 10 - 15 mg/kg/day BID for 15 days

    Drug: Albendazole

  • Placebo comparator
    Placebo

    Placebo BID for 15 days

    Drug: Placebo

Interventions

  • Albendazole 10 - 15 mg/kg/day BID for 15 days

  • DrugPlacebo

    Placebo BID for 15 days

06

What researchers measure

Primary outcomes

  1. Mean absolute reduction in eosinophil count from baseline

    Time frame: 12 months after treatment

Secondary outcomes

  1. Reduction in eosinophil count in more than 60% from baseline

    Time frame: 1 year

  2. Incidence of adverse drug events

    Time frame: 3, 6, 9 and 12 months after treatment

  3. Mean absolute reduction in eosinophil count

    Time frame: 3, 6, 9 months after treatment

07

Study locations

1 site
  • Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
    Buenos Aires, 1425, Argentina
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of Jul 2015 and a completion of Jul 2025. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2008
First posted
Sep 19, 2008
Start
Sep 2008
Primary completionActual
Jul 2015
CompletionEst.
Jul 2025
Last update
Mar 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00755560
Lead sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Responsible party
Dr Jaime Altcheh (Service Head, Parasitology and Chagas Service, Hospital de Niños R. Gutierrez de Buenos Aires) — Principal investigator
First posted
Sep 19, 2008
Start date
Sep 2008
Primary completion
Jul 2015
Completion
Jul 2025 (estimated)
Last update
Mar 2, 2023

Study contacts

Jaime Altcheh, MD
study chair · Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Hector Freilij, MD
principal investigator · Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Albendazole

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