ToxocariasisPhase 3NCT00755560
Treatment of Asymptomatic Toxocariasis With Albendazole in Children
A Phase 3 study testing Albendazole in people with Toxocariasis, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Toxocariasis
- What is being tested?
- Albendazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteArgentina
- Study dates
- Sep 2008to Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric ambulatory patients with asymptomatic toxocariasis
- Children 2 - 15 years old
- Absolute eosinophil count > 1100 / mm3
- Normal ophthalmoscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Buenos Aires, 1425
About this study
Official title: Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial
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.
- Conditions
- Toxocariasis
- Being tested
- Albendazole, Placebo
- Keywords
- Toxocara, Pediatrics, Albendazole, eosinophilia, parasitology, pediatric clinical pharmacology
- Medical subject headings
- Toxocariasis, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
Albendazole 10 - 15 mg/kg/day BID for 15 days
PlaceboDrug
Placebo BID for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Albendazole | Active comparator | Albendazole 10 - 15 mg/kg/day BID for 15 days Receives: Drug: Albendazole |
| Placebo | Placebo comparator | Placebo BID for 15 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute reduction in eosinophil count from baseline
Measured: 12 months after treatment
Secondary outcomes (3)
Reduction in eosinophil count in more than 60% from baseline
Measured: 1 year
Incidence of adverse drug events
Measured: 3, 6, 9 and 12 months after treatment
Mean absolute reduction in eosinophil count
Measured: 3, 6, 9 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2015
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxocariasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires
- Investigators
- Jaime Altcheh, MD, Study chair, Parasitology Division, Children's Hospital "R Gutierrez" of Buenos AiresHector Freilij, MD, Principal investigator, Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755560
- Sponsor's protocol ID
- TOXOCARA-ALBENDAZOLE
- Status last verified
- Feb 2023
- First submitted
- 17 Sep 2008
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00755560
- Acronym / sponsor ID
- TOXOCARA-ALBENDAZOLE
- Conditions
- Toxocariasis
- Keywords
- Toxocara, Pediatrics, Albendazole, eosinophilia, parasitology, pediatric clinical pharmacology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos AiresUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albendazole | Active comparator | Drug: AlbendazoleAlbendazole 10 - 15 mg/kg/day BID for 15 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo BID for 15 days |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric ambulatory patients with asymptomatic toxocariasis
- Children 2 - 15 years old
- Absolute eosinophil count > 1100 / mm3
- Normal ophthalmoscopy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbendazoleAlbendazole 10 - 15 mg/kg/day BID for 15 days | Drug | Albendazole |
| PlaceboPlacebo BID for 15 days | Drug | Placebo |
Primary outcome
Mean absolute reduction in eosinophil count from baseline
Time frame: 12 months after treatment
3 secondary outcomes
Reduction in eosinophil count in more than 60% from baseline
Time frame: 1 year
Incidence of adverse drug events
Time frame: 3, 6, 9 and 12 months after treatment
Mean absolute reduction in eosinophil count
Time frame: 3, 6, 9 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albendazole in people with Toxocariasis, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute reduction in eosinophil count from baseline (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.