Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01678599
• Date of registration: 01/03/2012
• Prospective Registration: No
• Primary sponsor: Drugs for Neglected Diseases
• Public title: Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease PCR
• Scientific title: Optimization of Sampling Procedure for PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease Treated With Benznidazole in Aiquile, Bolivia
• Date of first enrolment: April 2011
• Target sample size: 220
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01678599
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Bolivia

Contacts

• Name: Lourdes Loza, Biochemist
• Affiliation: Medicin Sans Frontièrs

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age between > 18 - 60 years

- Diagnosis of T. cruzi infection by Chagas serology. Two out of three serological tests
must be positive [conventional ELISA, recombinant ELISA, or HAI)

- Written informed consent form

Exclusion Criteria:

- Women in reproductive age who have a positive pregnancy test at screening, or who are
breastfeeding Note: Women in reproductive age must accept to use a contraceptive
method during the entire treatment phase of the trial

- Current presentation of serious health condition such as: active pulmonary
tuberculosis and clinical signs of liver or renal failure.

- Chagasic cardiomyopathy stage II, III and IV (according to the NYHA classification)

- Subjects requiring pacemaker implantation or other serious cardiac conduction defects

- History of CD treatment with benznidazole or nifurtimox at any time in the past

- Inability to comply with follow-up and/or not having a permanent address

- History of alcohol abuse or any other drug addiction



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chagas Disease

Intervention(s)

Drug: Benznidazole

Primary Outcome(s)

The primary endpoints are: - A positive or negative PCR at baseline (BL) among serology positive patients. [Time Frame: Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits.]

- Identification of the optimal relationship between sensitivity and feasibility at baseline. [Time Frame: Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits.]

Secondary Outcome(s)

- Relative reduction [(parasite count at baseline - parasite count at EOT, 6 and 12 months)/parasite count at baseline] of parasitemia - to be evaluated through parasite load at EOT, 6 and 12 months through quantitative PCR. [Time Frame: Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits.]

- The proportion of patients who convert from PCR (+) at baseline to PCR (-) at EOT - to be estimated using 1) the current sampling schedule (CS), the most sensitive one and the optimal one. [Time Frame: Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits.]

- Identification of the optimal relationship between sensitivity and Identification of the optimal relationship between sensitivity and feasibility at End Of Treatment (EOT) [Time Frame: Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits.]

- The proportion of patients who convert from PCR (+) at baseline to PCR (-) at 6 and 12 months follow-up - to be estimated using 1) the current sampling schedule (CS) and the optimal one (based on EOT data). [Time Frame: Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits.]

Secondary ID(s)

MSF/DNDi-CD-PCR-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medecins Sans Frontieres, Netherlands