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

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ClinicalTrials.gov Identifier: NCT02636803
Recruitment Status : Withdrawn (not going to be conducted)
First Posted : December 22, 2015
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Universidad Peruana Cayetano Heredia
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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).

Condition or disease Intervention/treatment Phase
Helminthiasis Drug: oxfendazole Drug: albendazole Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: oxfendazole 6 mg/kg
patients receive 6 mg/kg oxfendazole once
Drug: oxfendazole
group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses

Experimental: oxfendazole 30 mg/kg
patients receive 30 mg/kg oxfendazole once
Drug: oxfendazole
group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses

Experimental: oxfendazole 6 mg/kg 3 times
patients receive 6 mg/kg oxfendazole three times
Drug: oxfendazole
group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses

Active Comparator: albendazole 400 mg
patients receive 400 mg albendazole once
Drug: albendazole
group receives one 400 mg dose of albendazole




Primary Outcome Measures :
  1. Cure of Trichuris trichiura [ Time Frame: day 21 following treatment ]
    Cure of infection (Clinical Cure) shown by absence of Trichuris eggs in stool examinations at Day 21, using Kato Katz test.

  2. Reduction in Trichuis trichiura eggs (compared to pretreatment) [ Time Frame: day 21 following treatment ]
    Reduction (compared to baseline) of Trichuris eggs in stool examinations at 21, using Kato Katz test.


Secondary Outcome Measures :
  1. Cure of other intestinal helminths [ Time Frame: day 21 following treatment ]
    Absence of Ascaris, Necator eggs in stool using Kato Katz test

  2. Safety and tolerability of oxfendazole in the treatment of adult patients assessed by cumulative adverse events [ Time Frame: treatment through day 21 following treatment ]
    Cumulative adverse events following treatment up to Day 21



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636803


Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Universidad Peruana Cayetano Heredia
Investigators
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Principal Investigator: 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 Universidad Nacional Mayor de San Marcos

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02636803     History of Changes
Other Study ID Numbers: OXF2
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: posting to CT.gov and publication

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
trichuris
hookworms
Ascaris
Additional relevant MeSH terms:
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Helminthiasis
Trichuriasis
Parasitic Diseases
Enoplida Infections
Adenophorea Infections
Nematode Infections
Albendazole
Oxfendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents