Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults

NCT02636803 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: OXF2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to provide data on the efficacy of oxfendazole against Trichuris trichiura at different doses in comparison to the standard single 400 mg dose of albendazole. In addition, the study will provide data on oxfendazole efficacy against other common nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenalis, Necator americanus).

Conditions

Helminthiasis

Keywords

trichuris; hookworms; Ascaris

Outcome Measures

Primary Outcomes (2)

• Cure of Trichuris trichiura

  Cure of infection (Clinical Cure) shown by absence of Trichuris eggs in stool examinations at Day 21, using Kato Katz test.

  day 21 following treatment

• Reduction in Trichuis trichiura eggs (compared to pretreatment)

  Reduction (compared to baseline) of Trichuris eggs in stool examinations at 21, using Kato Katz test.

  day 21 following treatment

Secondary Outcomes (2)

• Cure of other intestinal helminths

  day 21 following treatment

• Safety and tolerability of oxfendazole in the treatment of adult patients assessed by cumulative adverse events

  treatment through day 21 following treatment

Study Arms (4)

oxfendazole 6 mg/kg

EXPERIMENTAL

patients receive 6 mg/kg oxfendazole once

Drug: oxfendazole

oxfendazole 30 mg/kg

EXPERIMENTAL

patients receive 30 mg/kg oxfendazole once

Drug: oxfendazole

oxfendazole 6 mg/kg 3 times

EXPERIMENTAL

patients receive 6 mg/kg oxfendazole three times

Drug: oxfendazole

albendazole 400 mg

ACTIVE COMPARATOR

patients receive 400 mg albendazole once

Drug: albendazole

Interventions

oxfendazole DRUG

group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses

oxfendazole 30 mg/kg; oxfendazole 6 mg/kg; oxfendazole 6 mg/kg 3 times

albendazole DRUG

group receives one 400 mg dose of albendazole

albendazole 400 mg

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written or witnessed oral informed consent has been obtained.
• Is willing to comply with the requirements of the protocol and particularly to provide 4 stool samples, pretreatment and 7, 14 and 21 days after treatment.
• Female patients of child bearing potential, who are using an established method of birth control (surgically sterile, intra-uterine contraceptive device, oral contraceptives, diaphragm in combination with contraceptive cream or foam, or condom in combination with contraceptive cream or foam)

You may not qualify if:

• The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.
• Presence of other helminths without Trichuris trichiura. Note: Non-target species may be present and details of response will be recorded.
• The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.
• The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.
• The patient has received an investigational drug within 30 days or 5 half-lives (whichever is longer) of the screening visit or is scheduled to receive such a drug during the study period.
• The patient has a concomitant infection or any other underlying disease that would compromise the diagnosis and the evaluation of the response to the study medication.
• The patient has a known history of renal dysfunction (plasma creatinine ≥ 1.5 times upper limit of normal for age) or hepatic dysfunction (liver enzymes ≥ 1.5
• Patient that is unwilling or unable to take part in this study.
• The patient has previously been enrolled in the study.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Universidad Peruana Cayetano Heredia: collaborator

MeSH Terms

Conditions

Helminthiasis; Hookworm Infections

Interventions

oxfendazole; Albendazole

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections; Strongylida Infections; Secernentea Infections; Nematode Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Robert H Gilman, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Hector H Garcia, MD, PhD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

• Richard J Horton, MB BChir, MRCGP, FFPM

  Tropical Projects

  PRINCIPAL INVESTIGATOR

• Armando E Gonzalez, DVM, PhD

  National University of San Marcos, Peru

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 22, 2015
• Study Start: November 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: February 1, 2021
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share