Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease (PCR)
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ClinicalTrials.gov Identifier: NCT01678599 |
Recruitment Status :
Completed
First Posted : September 5, 2012
Last Update Posted : June 25, 2018
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Condition or disease | Intervention/treatment | Phase |
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Chagas Disease | Drug: Benznidazole | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 220 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
Benznidazol
This is a single arm, open label study; therefore, all subjects enrolled will receive benznidazol.
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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 |
- 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. ]
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
- - 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 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. ]
- - 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. ]
- - 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. ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678599
Bolivia | |
Medicin Sans Frontièrs (MSF) | |
Aiquile, Bolivia |
Principal Investigator: | Lourdes Loza, Biochemist | Medicin Sans Frontièrs |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Drugs for Neglected Diseases |
ClinicalTrials.gov Identifier: | NCT01678599 |
Other Study ID Numbers: |
MSF/DNDi-CD-PCR-01 |
First Posted: | September 5, 2012 Key Record Dates |
Last Update Posted: | June 25, 2018 |
Last Verified: | June 2018 |
Chagas Disease PCR diagnosis |
Chagas Disease Trypanosomiasis Euglenozoa Infections Protozoan Infections Parasitic Diseases Benzonidazole Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |