The main objective of this study is to provide data on the efficacy profile of different doses of oxfendazole when used in Trichuris trichiura infection. The drug will be also be examined for efficacy against other common nematodes encountered in man (Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus). The study will also provide data on the safety and tolerability of the oxfendazole in patients.
Male or female outpatient, more than 18 years and less than 65 years of age.
Written or witnessed oral informed consent has been obtained.
Trichuris trichiura demonstrated in stool samples obtained during the week before enrolment: The presence of Ascaris lumbricoides, Necator americanus, Ancylostoma duodenalis or other helminths will not be a cause for exclusion.
Willingness to comply with the requirements of the protocol and particularly to provide 4 stool samples, pretreatment and 7, 14 and 21 days after treatment.
The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.
Presence of other helminths without Trichuris trichiura. 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.
Parallel
Oxfendazole
Drugoral suspension
Albendazole
Drugtablet
cure d14
absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
cure d7
absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
improvement d21
reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
improvement d14
reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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Oxfendazole Development Group
Lead sponsor
Universidad Peruana Cayetano Heredia
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
