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

NCT ID: NCT02636803

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2021-02-28

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).

Detailed Description

This is an open, comparative study in adult patients with proven intestinal infection with Trichuris trichiura. Patients meeting the study entry criteria will receive either 6mg/kg, or 30 mg/kg of oxfendazole as a single oral dose or 6 mg/kg orally for three days or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined 7, 14 and 21 days after treatment.

Two hundred clinically evaluable patients of either gender, 16 - 65 years of age, presenting with proven Trichuris trichiura infection, recruited from one centre, will be included in the study. there will be 15 patients in each treatment group. Duration of accrual will be determined in discussion with the clinical site in Iquitos, Peru.

Conditions

Helminthiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

oxfendazole 6 mg/kg

patients receive 6 mg/kg oxfendazole once

Group Type: EXPERIMENTAL

oxfendazole

Intervention Type: DRUG

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

oxfendazole 30 mg/kg

patients receive 30 mg/kg oxfendazole once

Group Type: EXPERIMENTAL

oxfendazole

Intervention Type: DRUG

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

oxfendazole 6 mg/kg 3 times

patients receive 6 mg/kg oxfendazole three times

Group Type: EXPERIMENTAL

oxfendazole

Intervention Type: DRUG

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

albendazole 400 mg

patients receive 400 mg albendazole once

Group Type: ACTIVE_COMPARATOR

albendazole

Intervention Type: DRUG

group receives one 400 mg dose of albendazole

Interventions

oxfendazole

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

Intervention Type: DRUG

albendazole

group receives one 400 mg dose of albendazole

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written or witnessed oral informed consent has been obtained.

2. Has Trichuris trichiura demonstrated in stool samples obtained during the week before enrolment: The presence of other helminths: Enterobius vermicularis, Ascaris lumbricoides, Necator americanus, Ancylostoma duodenalis will not be a cause for exclusion.

3. 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.

4. 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)

9. Patient that is unwilling or unable to take part in this study.

10. The patient has previously been enrolled in the study.

Exclusion Criteria

1. The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.

2. Presence of other helminths without Trichuris trichiura. Note: Non-target species may be present and details of response will be recorded.

3. The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.

4. The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.

5. 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.

6. 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.

7. 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert H Gilman, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Hector H Garcia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Peruana Cayetano Heredia

Richard J Horton, MB BChir, MRCGP, FFPM

Role: PRINCIPAL_INVESTIGATOR

Tropical Projects

Armando E Gonzalez, DVM, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of San Marcos, Peru

Other Identifiers

OXF2

Identifier Type: -

Identifier Source: org_study_id