Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease

NCT01755403 — Phase 4, Completed, 52 participants, Barcelona Centre for International Health Research

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Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.

Registry	NCT01755403, acronym CINEBENZ
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	52 (Actual)
Sponsor	Barcelona Centre for International Health Research (Other)
Conditions	Chagas Disease
Interventions	Benznidazole (Drug)
Dates	start 2012-12-01, primary completion 2013-11-01, completion 2013-11-01, first posted 2012-12-24, last updated 2015-05-27
Locations	1 site in Spain

-Summary

o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.

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+Arms and interventions

Arm	Type	Interventions	Description
Benznidazole	Other	Drug: Benznidazole

Benznidazole (Drug)

+Outcome measures

Primary outcomes

Population pharmacokinetic parameters of Benznidazole [2 months (treatment period)]: Population pharmacokinetic model development

Secondary outcomes

Adverse reactions [2 months (treatment period)]: Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration.

+Eligibility

Sex: All, ages: 18 Years to 60 Years

Inclusion Criteria:

* Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests.
* Patients with Chronic Chagas Disease who are going to start treatment with Benznidazole.
* Any gender.
* All the participants must agree to participate in the study and must sign the informed consent.

Exclusion Criteria:

* Patients younger than 18.
* Patients with previous hypersensitivity to Benznidazole.
* Immunocompromised patients as AIDS, cancer, chemotherapy, longterm corticoids need, primary immunodeficiency, or any other.
* Hepatic dysfunction
* Renal dysfunction: serum creatinin higher than 3 mg/dl.
* Pregnancy or lactation.
* Low adhesion to treatment or check-up.
* Impossibility of follow-up.
* Severe adverse reaction to Benznidazole.
* Any other situation that could be risky for the patient.

+Locations (1)

Facility	City	Country	Status
International Health Department, Hospital Clinic, Barcelona	Barcelona, Catalonia	Spain

+Publications

Results publication: Aldasoro E, Posada E, Requena-Mendez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060-1067. doi: 10.1093/jac/dkx516. PMID 29351667
Results publication: Soy D, Aldasoro E, Guerrero L, Posada E, Serret N, Mejia T, Urbina JA, Gascon J. Population pharmacokinetics of benznidazole in adult patients with Chagas disease. Antimicrob Agents Chemother. 2015;59(6):3342-9. doi: 10.1128/AAC.05018-14. Epub 2015 Mar 30. PMID 25824212

+Investigators

Joaquim Gascón, PhD, Principal investigator, Barcelona Centre for International Health Research (CRESIB)