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

Primary Purpose

Helminthiasis

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

oxfendazole

albendazole

About this trial

This is an interventional treatment trial for Helminthiasis focused on measuring trichuris, hookworms, Ascaris

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Is a female who is pregnant, lactating or planning a pregnancy during the study, or is not practicing any form of contraception (see inclusion criteria (4.2.5).
Patient that is unwilling or unable to take part in this study.
The patient has previously been enrolled in the study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

oxfendazole 6 mg/kg

oxfendazole 30 mg/kg

oxfendazole 6 mg/kg 3 times

albendazole 400 mg

Arm Description

patients receive 6 mg/kg oxfendazole once

patients receive 30 mg/kg oxfendazole once

patients receive 6 mg/kg oxfendazole three times

patients receive 400 mg albendazole once

Outcomes

Primary Outcome Measures

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.

Reduction in Trichuis trichiura eggs (compared to pretreatment)

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

Secondary Outcome Measures

Cure of other intestinal helminths

Absence of Ascaris, Necator eggs in stool using Kato Katz test

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

Cumulative adverse events following treatment up to Day 21

Full Information

NCT ID

NCT02636803

First Posted

December 14, 2015

Last Updated

August 13, 2019

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Universidad Peruana Cayetano Heredia

1. Study Identification

Unique Protocol Identification Number

NCT02636803

Brief Title

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

Official Title

An Open Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Withdrawn

Why Stopped

not going to be conducted

Study Start Date

November 2019 (Anticipated)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Universidad Peruana Cayetano Heredia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Helminthiasis

Keywords

trichuris, hookworms, Ascaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oxfendazole 6 mg/kg

Arm Type

Experimental

Arm Description

patients receive 6 mg/kg oxfendazole once

Arm Title

oxfendazole 30 mg/kg

Arm Type

Experimental

Arm Description

patients receive 30 mg/kg oxfendazole once

Arm Title

oxfendazole 6 mg/kg 3 times

Arm Type

Experimental

Arm Description

patients receive 6 mg/kg oxfendazole three times

Arm Title

albendazole 400 mg

Arm Type

Active Comparator

Arm Description

patients receive 400 mg albendazole once

Intervention Type

Drug

Intervention Name(s)

oxfendazole

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

albendazole

Intervention Description

group receives one 400 mg dose of albendazole

Primary Outcome Measure Information:

Title

Cure of Trichuris trichiura

Description

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

Time Frame

day 21 following treatment

Title

Reduction in Trichuis trichiura eggs (compared to pretreatment)

Description

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

Time Frame

day 21 following treatment

Secondary Outcome Measure Information:

Title

Cure of other intestinal helminths

Description

Absence of Ascaris, Necator eggs in stool using Kato Katz test

Time Frame

day 21 following treatment

Title

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

Description

Cumulative adverse events following treatment up to Day 21

Time Frame

treatment through day 21 following treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written or witnessed oral informed consent has been obtained. 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. 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) Exclusion Criteria: 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 Is a female who is pregnant, lactating or planning a pregnancy during the study, or is not practicing any form of contraception (see inclusion criteria (4.2.5). Patient that is unwilling or unable to take part in this study. The patient has previously been enrolled in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert H Gilman, MD

Organizational Affiliation

Johns Hopkins Bloomberg School of Public Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hector H Garcia, MD, PhD

Organizational Affiliation

Universidad Peruana Cayetano Heredia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Richard J Horton, MB BChir, MRCGP, FFPM

Organizational Affiliation

Tropical Projects

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Armando E Gonzalez, DVM, PhD

Organizational Affiliation

National University of San Marcos, Peru

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

posting to CT.gov and publication

Learn more about this trial

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

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