A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults

Phase 2

Conditions: B79 Trichuriasis
Trichuriasis

Registration Number: PER-022-23

Lead Sponsor: ASOCIACION BENEFICA PRISMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Without startig enrollment

Sex: All

Target Recruitment: 0

Inclusion Criteria

This trial will recruit generally healthy subjects who meet all the following inclusion criteria:
1.Male or female aged 18-65 years, inclusive and weigh =55 kg.
2.Are willing to participate in this trial, as evidenced by written or witnessed oral informed consent
3.T. trichiura* is demonstrated in a stool sample obtained within 14 days before randomization and enrollment
*The presence of A. lumbricoides, N. americanus, A. duodenalis, or other helminths will not be a cause for exclusion.
4.Are willing to comply with the requirements of this protocol, particularly to provide four stool samples and two blood samples* over approximately 4- 6 weeks.
*An extra stool or blood sample might be required if the samples are not collected within the appropriate time frame or to follow up on abnormal laboratory tests.
5.Females of reproductive potential must have a negative serum pregnancy test within 10 days or a negative urine pregnancy test within 72 hours of the first study drug administration.*
*If a woman of child bearing potential is on an injectable form of contraception, a single serum pregnancy test at screening (Days -10 to -3) is acceptable. If the woman is not using an injectable form of contraception, a pregnancy test must be negative within 72 hours of the first study drug administration.
6.Female subjects of childbearing potential must be using effective contraception*
*Effective methods of contraception include: abstinence from sexual intercourse, monogamous relationship with a vasectomized partner, male condoms with spermicide, surgical sterility, intrauterine contraceptive device, oral or injectable contraceptives, diaphragm in combination with contraceptive cream or foam. Females aged =50 years who have had no menstrual periods for 1 year may be enrolled. Females must agree to continue effective contraception for approximately 28 days following the last study drug administration.
7.Male subjects must agree to abstain from sexual intercourse with female partner(s) of child-bearing potential or must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug. If their partner is of child-bearing potential, their partner must additionally be using one of the following methods: hormonal contraception, intrauterine device, diaphragm, or cervical cap. Spermicides alone are not an acceptable method of contraception. No sperm donations should occur for 90 days after the last dose of study therapy.

Exclusion Criteria

Subjects will not be able to participate if they meet any of the following exclusion criteria:
1.Has demonstrated a previous hypersensitivity reaction to oxfendazole or a related compound (e.g. albendazole, mebendazole)
2.Has a diarrheal disease that would interfere with the evaluation of stool samples*
* more than 6 stools per day or stools that are completely liquid
3.Has received an antihelminthic within 14 days before enrolment
4.Has received an investigational drug within 30 days before the screening visit or is scheduled to receive such a drug during this trial
5.Has a concomitant infection or another underlying disease that would compromise the safety, diagnosis, and evaluation of responses to the study drug
6.Has a known history of renal dysfunction or plasma creatinine =1.5 times the upper limit of normal (ULN) for age
7.Has a known history of hepatic dysfunction or AST, ALT, total bilirubin =1.5 times the ULN
8. Has a known history of significant cardiac disease (arrhythmias, structural heart disease, congestive heart failure, rheumatic heart disease requiring continued antibiotics)
9.Has a hemoglobin that is less than 8 g/dL.
10.Is a female who is pregnant, lactating, or planning a pregnancy during this trial (up to days 28 after the last scheduled dose),
11.Has previously been enrolled in this trial
12.Has any condition that would, in the investigator’s opinion, interfere with this trial or pose a greater risk than benefit to the participant.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kato-Katz method. From two stool samples (each tested in duplicate)<br> NAME OF THE RESULT: Cure of the infection (clinical cure) demonstrated by the absence of T. trichiura eggs.<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Visit 03, days 18 to 23 of the study.

Secondary Outcome Measures