Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora

NCT ID: NCT01192802

Last Updated: 2013-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-07-31

Brief Summary

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Albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy in the school children population. The aim of this study is to evaluate the efficacy of the albendazole one versus two and three doses, in school children infected with intestinal helminth.

Detailed Description

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Conditions

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Intestinal Diseases Helminthiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1 dose, Albendazole , tablet

Group Type ACTIVE_COMPARATOR

albendazole

Intervention Type DRUG

single 1 tablet of 400 mg of albendazole

2 doses, albendazole, tablet

1 tablet of 400 mg of albendazole per day for two consecutive days

Group Type ACTIVE_COMPARATOR

albendazole

Intervention Type DRUG

1 tablet of 400 mg of albendazole per day for two consecutive days

3 doses albendazole, 400mg, tablet

Group Type ACTIVE_COMPARATOR

albendazole

Intervention Type DRUG

1 tablet of 400 mg of albendazole per day for three consecutive days

Interventions

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albendazole

1 tablet of 400 mg of albendazole per day for three consecutive days

Intervention Type DRUG

albendazole

single 1 tablet of 400 mg of albendazole

Intervention Type DRUG

albendazole

1 tablet of 400 mg of albendazole per day for two consecutive days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* presence of intestinal helminths eggs in the stool

Exclusion Criteria

* allergy to imidazole derivate
* No intestinal helminths
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albert Schweitzer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Medical Research Unit

Locations

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Medical research Unit of Lambaréné

Lambaréné, Moyen-Ogooué Province, Gabon

Site Status

Countries

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Gabon

References

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Adegnika AA, Zinsou JF, Issifou S, Ateba-Ngoa U, Kassa RF, Feugap EN, Honkpehedji YJ, Dejon Agobe JC, Kenguele HM, Massinga-Loembe M, Agnandji ST, Mordmuller B, Ramharter M, Yazdanbakhsh M, Kremsner PG, Lell B. Randomized, controlled, assessor-blind clinical trial to assess the efficacy of single- versus repeated-dose albendazole to treat ascaris lumbricoides, trichuris trichiura, and hookworm infection. Antimicrob Agents Chemother. 2014 May;58(5):2535-40. doi: 10.1128/AAC.01317-13. Epub 2014 Feb 18.

Reference Type DERIVED
PMID: 24550339 (View on PubMed)

Related Links

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http://www.lambarene.org

Medical Research Unit of the Albert Schweitzer Hospital

Other Identifiers

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Albendazole-001

Identifier Type: -

Identifier Source: org_study_id

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