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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Drugs for Neglected Diseases.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Medecins Sans Frontieres
Information provided by (Responsible Party):
Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:
NCT01678599
First received: March 1, 2012
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to estimate the gain in sensitivity of several multiple-sample strategies of PCR samples with respect to the current standard (single sample of 10 ml) to detect Chagas chronic stage at baseline and to identify the optimal sampling strategy based on the sensitivity, cost,the completeness of sampling and the acceptability for study patients.


Condition Intervention Phase
Chagas Disease
Drug: Benznidazole
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Optimization of Sampling Procedure for PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease Treated With Benznidazole in Aiquile, Bolivia

Resource links provided by NLM:


Further study details as provided by Drugs for Neglected Diseases:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • - 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. ] [ Designated as safety issue: No ]

    For BL and EOT visits, blood samples will be as follows: one initial blood of 10 mL (Sample 1), followed by 1 sample of 5mL collected immediately following (Sample 2); plus one blood sample of 10mL collected 1 week later (Sample 3).

    Once the optimal strategy has been defined for EOT visit (see section 10.7), this will be the strategy of blood collection to be used at the 6 and 12 months follow-up visits



Secondary Outcome Measures:
  • - 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. ] [ Designated as safety issue: No ]
  • - 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. ] [ Designated as safety issue: No ]
  • - 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. ] [ Designated as safety issue: No ]
  • - 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Benznidazol
This is a single arm, open label study; therefore, all subjects enrolled will receive benznidazol.
Drug: Benznidazole
All patients participating in this study will be treated with Benznidazole, 5mg/Kg/day PO BID for 60 days with a maximum daily dose of 300mg, as per routine care provided by MSF in rural communities in Aiquile. For patients > 60 kg, the total dose should be calculated (5mg/Kg x Weight x 60 days) and treatment duration should be adjusted/prolonged accordingly. This treatment is in accordance with the local recommendations from the Ministerio de Salud y Deportes de Bolivia.
Other Name: LAFEPE Benznidazol

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  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678599

Locations
Bolivia
Medicin Sans Frontièrs (MSF)
Aiquile, Bolivia
Sponsors and Collaborators
Drugs for Neglected Diseases
Medecins Sans Frontieres
Investigators
Principal Investigator: Lourdes Loza, Biochemist Medicin Sans Frontièrs
  More Information

Additional Information:
Publications:
Responsible Party: Drugs for Neglected Diseases
ClinicalTrials.gov Identifier: NCT01678599     History of Changes
Other Study ID Numbers: MSF/DNDi-CD-PCR-01
Study First Received: March 1, 2012
Last Updated: August 30, 2012
Health Authority: Bolivia: Collective of Applied Studies and Social Development (CEADES)
Spain: Médicins Sans Frontières(MSF) - Doctors without Borders
Bolivia: Ministry of Health

Keywords provided by Drugs for Neglected Diseases:
Chagas Disease
PCR
diagnosis

Additional relevant MeSH terms:
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Benzonidazole
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014