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

Helminthiasis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02636803
• Other study ID #: OXF2
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 2019
• Est. completion date: February 2021

Study information

• Verified date: August 2019
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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)

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

8. 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).

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

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

Related Conditions & MeSH terms

• Helminthiasis
• Trichuriasis

Intervention

Drug:
• oxfendazole
group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses
• albendazole
group receives one 400 mg dose of albendazole

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Universidad Peruana Cayetano Heredia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Cure of other intestinal helminths	Absence of Ascaris, Necator eggs in stool using Kato Katz test	day 21 following treatment
Secondary	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	treatment through day 21 following treatment