Browsing by Autor "Lourdes Ortiz"

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2128. Lack of Congenital Transmission in Infants Born of Female Patients with Chagas Disease who Became Pregnant During a Nifurtimox Study (CHICO and CHICO SECURE Study)
(Oxford University Press, 2022) A L T C H E H Jaime; Teresa González Ramírez; Víctor Parra Sierra; Guillermo Moscatelli; Juan Carlos Dib; Jimy Pinto; Lourdes Ortiz; Andrea Falaschi
Abstract Background There is some concern about the safety of nifurtimox (NF) for the offspring of treated women. Potential genotoxicity of NF was reported in in vitro models. However, the evidence to support the risks in fetal development is lacking for humans. In addition, a preventative effect over transplacental transmission was reported in girls and women with T.cruzi infection treated before pregnancy (mainly with benznidazole). Methods A multicenter, randomized, double-blind phase 3 clinical trial (NCT02625974) was set up to evaluate safety and efficacy of NF. A total of 330 patients, younger 18 years old, were enrolled, 67 were females of child-bearing age. The enrolled females of childbearing age agreed to use an effective method of contraception until 3 months after the last administration of NF. Pregnancy tests were performed at screening, during treatment and 30 days after end of treatment. Results No pregnancies were reported during treatment period. There were 5 pregnancies reported during the 1st year of post-treatment follow-up and another 21 pregnancies during the additional 3-year follow-up period. Two mothers did not consent to have their babies tested for T cruzi infection, and in one case an abortion was reported. Two women gave birth twice. There was information about transplacental transmission available in 18 babies. All mothers were T.cruzi RT-PCR negative at the end of the treatment period and remained negative during follow up. All newborns were live, healthy full-term and of weight appropriate for their gestational age, and had no perinatal complications except one baby who was healthy but small for gestational age. T.cruzi infection was ruled out by a negative direct parasitological test during the first days of life in 12 infants , and /or by ELISA T.cruzi serology at 8 -12 months of age in 14 infants, which was negative in all cases. Conclusion Our results showed that treatment of females on childbearing age with nifurtimox may prevent transplacental transmission of CD as was reported previously for benznidazole. Disclosures Jaime ALTCHEH, Sr., MD,PhD, Bayer: Advisor/Consultant.
A Phase 2, Randomized, Multicenter, Placebo-Controlled, Proof-of-Concept Trial of Oral Fexinidazole in Adults With Chronic Indeterminate Chagas Disease
(Oxford University Press, 2022) Faustino Torrico; Joaquím Gascón; Lourdes Ortiz; Jimy Pinto; Gimena Rojas; Alejandro Palacios; Fabiana Barreira; Bethania Blum; Alejandro G. Schijman; Michel Vaillant
NCT02498782.
A strategy for scaling up access to comprehensive care in adults with Chagas disease in endemic countries: The Bolivian Chagas Platform
(Public Library of Science, 2017) María‐Jesús Pinazo; Jimy Pinto; Lourdes Ortiz; Jareth Sánchez; Wilson García; Ruth Saravia; Mirko Rojas Cortez; Silvia Moriana; Enric Grau; Daniel Lozano
This strategy provides a solution to unmet demands in the care of patients with CD, improving access to diagnosis and treatment. Further scaling up of diagnosis and treatment will be based on the expansion of the model of care to the NHS structures. Its sustainability will be ensured as it will build on existing local resources in Bolivia. Still human trained resources are scarce and the high staff turnover in Bolivia is a limitation of the model. Nevertheless, in a preliminary two-years-experience of scaling up this model, this limitations have been locally solved together with the health local authorities.
Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: a proof-of-concept study
(Elsevier BV, 2024) Lizeth Rojas Panozo; Silvia Rivera Nina; Diana P. Wehrendt; Aina Casellas; Lilian Pinto; Susana Méndez; Chi-Wei Kuo; Daniel Lozano; Lourdes Ortiz; María‐Jesús Pinazo
Inter-American Development Bank.
Genetic polymorphism of Trypanosoma cruzi bloodstream populations in adult chronic indeterminate Chagas disease patients from the E1224 clinical trial
(Oxford University Press, 2021) Juan Carlos Ramı́rez; Gonzalo R. Acevedo; Carolina Torres; Rudy Parrado; Anabelle de la Barra; Sandro Villarroel; Lineth García; Joaquím Gascón; Lourdes Ortiz; Faustino Torrico
Genetic variability of T. cruzi bloodstream populations during post-treatment follow-up did not differ from that observed during chronic infection in the absence of treatment, suggesting that there were no selection events of E1224-resistant parasite populations. This is the first report documenting the genetic polymorphism of natural T. cruzi populations in chronic patients in the context of clinical trials with trypanocidal drugs.
New chemotherapy regimens and biomarkers for Chagas disease: the rationale and design of the TESEO study, an open-label, randomised, prospective, phase-2 clinical trial in the Plurinational State of Bolivia
(BMJ, 2021) Cristina Alonso‐Vega; Julio A. Urbina; Sergi Sanz; María‐Jesús Pinazo; Jimy Pinto; Virginia Gonzalez; Gimena Rojas; Lourdes Ortiz; Wilson García; Daniel Lozano
NCT03981523.
Real Time PCR for the Evaluation of Treatment Response in Clinical Trials of Adult Chronic Chagas Disease: Usefulness of Serial Blood Sampling and qPCR Replicates
(2018) Rudy Parrado; Ramírez Jc; Anabelle de la Barra; Cristina Alonso‐Vega; Natalia Juiz; Lourdes Ortiz; Daniel Illanes; Faustino Torrico; Joaquím Gascón; Fabiana Alves
Abstract This work evaluated a serial blood sampling procedure to enhance the sensitivity of duplex real time PCR (qPCR) for baseline detection and quantification of parasitic loads and post-treatment identification of failure in the context of clinical trials for treatment of chronic Chagas disease, namely DNDi-CH-E1224-001 ( NCT01489228 ) and MSF-DNDi PCR sampling optimization study ( NCT01678599 ). Patients from Cochabamba (N= 294), Tarija (N = 257), and Aiquile (N= 220) were enrolled. Three serial blood samples were collected at each time-point, and qPCR triplicates were tested per sample. The first two samples were collected during the same day and the third one seven days later. A patient was considered PCR positive if at least one qPCR replicate was detectable. Cumulative results of multiple samples and qPCR replicates enhanced the proportion of pre-treatment sample positivity from 54.8 to 76.2%, 59.5 to 77.8%, and 73.5 to 90.2% in Cochabamba, Tarija, and Aiquile cohorts, respectively and increased cumulative detection of treatment failure from 72.9 to 91.7%, 77.8 to 88.9%, and 42.9 to 69.1% for E1224 low, short, and high dosage regimes, respectively; and from 4.6 to 15.9% and 9.5 to 32.1% for the benznidazole (BZN) arm in the DNDi-CH-E1224-001 and MSF-DNDi studies, respectively. The monitoring of patients treated with placebo in the DNDi-CH-E1224-001 trial revealed fluctuations in parasitic loads and occasional non-detectable results. This serial sampling strategy enhanced PCR sensitivity to detecting treatment failure during follow-up and has the potential for improving recruitment capacity in Chagas disease trials which require an initial positive qPCR result for patient admission.
Results and evaluation of the expansion of a model of comprehensive care for Chagas disease within the National Health System: The Bolivian Chagas network
(Public Library of Science, 2022) María‐Jesús Pinazo; Mirko Rojas Cortez; Ruth Saravia; Wilson Garcia-Ruiloba; Carlos Alberto do Nascimento Ramos; Jimy Pinto; Lourdes Ortiz; Mario Castellon; Nilce Mendoza-Claure; Daniel Lozano
After being recognized by the Chagas National Programme as a healthcare model aligned with national laws and priorities, the Bolivian platform of Chagas as an innovation, includes attributes that they have made it possible to expand the strategy at the national level and could also be adapted in other countries.
Small-RNA sequencing identifies serum microRNAs associated with abnormal electrocardiography findings in patients with Chagas disease
(Elsevier BV, 2025) Michael Mueller; Alice Blandino; Dominique Scherer; Inés Zulantay; Werner Apt; Nelson Varela; Marcelo Llancaqueo; Lineth García; Lourdes Ortiz; Emanuele Nicastri
Small-RNA Sequencing Identifies Serum Micrornas Associated with Abnormal Electrocardiography Findings in Patients with Chagas Disease
(RELX Group (Netherlands), 2025) Michael Müller; Alice Blandino; Dominique Scherer; Inés Zulantay; Werner Apt; Nelvis Figueroa; Mariela Paoli de Valeri; Lineth García; Lourdes Ortiz; Emanuele Nicastri
Treatment of adult chronic indeterminate Chagas disease with benznidazole and three E1224 dosing regimens: a proof-of-concept, randomised, placebo-controlled trial
(Elsevier BV, 2018) Faustino Torrico; Joaquím Gascón; Lourdes Ortiz; Cristina Alonso‐Vega; María‐Jesús Pinazo; Alejandro G. Schijman; Igor C. Almeida; Fabiana Alves; Nathalie Strub‐Wourgaft; Isabela Ribeiro
Use of rapid diagnostic tests (RDTs) for conclusive diagnosis of chronic Chagas disease – field implementation in the Bolivian Chaco region
(Public Library of Science, 2019) Daniel Lozano; Lizeth Rojas; Susana Méndez; Aina Casellas; Sergi Sanz; Lourdes Ortiz; María‐Jesús Pinazo; Marcelo Abril; Joaquím Gascón; Faustino Torrico
Chagas disease, caused by the parasite Trypanosoma cruzi, is the neglected tropical disease with a highest burden in Latin America. Its acute stage is mostly asymptomatic and goes unnoticed. Symptoms appear at the chronic stage, which is when diagnosis is usually made. This is based on the agreement of two conventional serological tests such as Enzyme-Linked Immunosorbent Assays (ELISAs). There are commercial kits with good sensitivity and specificity but their use is impractical in many highly endemic regions with poorly equipped laboratories. Luckily, several rapid diagnostic tests (RDTs) are available for the detection of anti-T. cruzi immunoglobulins. They are easy to operate, require no cold storage, provide fast turnaround of results, and some can work with a tiny volume of whole blood as sample. With the aim to field validate their use we compared an alternative algorithm based on a combination of RDTs with the standard based on ELISAs. In both cases a third test was available in case of discordance. RDTs were implemented by mobile teams in field campaigns to detect chronic T. cruzi-infections in the Chaco region of Bolivia. ELISAs were made in the reference laboratories located in the main hospitals of Yacuiba and Villa Montes, two major cities of the region. We enrolled 685 subjects who voluntarily participated in the study and had not been treated against the disease before. The agreement between the two main RDTs was 93.1% (638/685) (kappa index = 0.86; CI 95% 0.83-0.90). In comparison to the ELISAs algorithm, the combined use of the RDTs provided a sensitivity of 97.7% and a specificity of 96.1%. These results support the use of RDTs for the diagnosis of chronic Chagas disease in the studied region, and encourage their evaluation in other regions of Bolivia and other endemic countries.
Usefulness of Serial Blood Sampling and PCR Replicates for Treatment Monitoring of Patients with Chronic Chagas Disease
(American Society for Microbiology, 2018) Rudy Parrado; Juan Carlos Ramı́rez; Anabelle de la Barra; Cristina Alonso‐Vega; Natalia Juiz; Lourdes Ortiz; Daniel Illanes; Faustino Torrico; Joaquím Gascón; Fabiana Alves
This work evaluated a serial blood sampling procedure to enhance the sensitivity of duplex real-time quantitative PCR (qPCR) for baseline detection and quantification of parasitic loads and posttreatment identification of failure in the context of clinical trials for treatment of chronic Chagas disease, namely, DNDi-CH-E1224-001 (ClinicalTrials.gov registration no. NCT01489228) and the MSF-DNDi PCR Sampling Optimization Study (NCT01678599). Patients from Cochabamba (n = 294), Tarija (n = 257), and Aiquile (n = 220) were enrolled. Three serial blood samples were collected at each time point, and qPCR triplicates were tested for each sample. The first two samples were collected during the same day and the third one 7 days later. A patient was considered PCR positive if at least one qPCR replicate was detectable. Cumulative results of multiple samples and qPCR replicates enhanced the proportion of pretreatment sample positivity from 54.8% to 76.2%, 59.5% to 77.8%, and 73.5% to 90.2% in Cochabamba, Tarija, and Aiquile cohorts, respectively. This strategy increased the detection of treatment failure from 72.9% to 91.7%, 77.8% to 88.9%, and 42.9% to 69.1% for E1224 low-, short-, and high-dosage regimens, respectively, and from 4.6% to 15.9% and 9.5% to 32.1% for the benznidazole arm in the DNDi-CH-E1224-001 and MSF-DNDi studies, respectively. The addition of the third blood sample and third qPCR replicate in patients with nondetectable PCR results in the first two samples gave a small, non-statistically significant improvement in qPCR positivity. No change in clinical sensitivity was seen with a blood volume increase from 5 to 10 ml. The monitoring of patients treated with placebo in the DNDi-CH-E1224-001 trial revealed fluctuations in parasitic loads and occasionally nondetectable results. In conclusion, a serial sampling strategy enhanced PCR sensitivity to detecting treatment failure during follow-up and has the potential for improving recruitment capacity in Chagas disease trials, which require an initial positive qPCR result for patient admission.