Clinical Trials Logo
  1. Home
  2. Transplantation
  3. NCT05452148

Specific Genotypes/Phenotypes of Pneumocystis Jirovecii in Solid Organ Transplant Recipients: Potential Involvement of Mycophenolic Acid — IMPDH  

Transplantation Clinical Trial

Official title:
Emergence of Specific Genotypes/Phenotypes of Pneumocystis Jirovecii in Solid Organ Transplant Recipients: Potential Involvement of Mycophenolic Acid

Clinical Trial Summary

To determine the presence of IMDPH mutants of Pneumocystis jirovecii in solid organ transplant recipient with prior exposition to mycophenolic acid.

Clinical Trial Description

Mycophenolic acid (MPA) targets inosine 5'-monophosphate dehydrogenase (IMPDH) of human lymphocytes. It is used as an immunosuppressant to prevent rejection in solid organ transplant (SOT) recipients who are otherwise at risk for Pneumocystis pneumonia (PCP). We recently hypothesized that MPA exerts selective pressure on Pneumocystis given the in vitro antifungal activity of this drug on other fungi. In a single center study, we identified a missense mutation G1020A in the impdh gene, corresponding to an amino acid change Ala261Thr in IMPDH protein, among Pneumocystis isolates from MPA-treated SOT recipients. Considering that the IMPDH of MPA-resistant Candida albicans isolates harbors Thr at the analogous position, this mutation was considered to be a marker of Pneumocystis strain selection related to MPA exposure. The aim of this study is to strengthen these preliminary results with data from a large multicenter study. The study will be conducted in 26 centers in France. About one hundred patients with PCP will be enrolled. Pneumocystis isolates from SOT recipients exposed to MPA and from control patients (non-SOT recipients, not exposed to MPA) will be examined.The analysis of the impdh gene was combined with a multilocus sequence typing (MLST) method (mtLSUrRNA, cytochrome b and superoxide dismutase genes) characterized by a high discriminatory power. The expected results may show the presence of the G1020A mutation (Ala261Thr) in SOT recipients exposed to MPA and in none of the control patients not exposed to MPA. This mutation will be significantly associated with MPA exposure. It could also be associated with a specific multilocus genotype in SOT patients and none of the control patients. The study will confirm that the G1020A mutation (Ala261Thr) represents the signature of MPA exposure. The results of the analysis of the impdh gene combined with the MLST will highlight the selection under MPA pressure of specific strains of Pneumocystis, which circulate in the population of SOT recipients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05452148
Study type Observational
Source University Hospital, Brest
Contact Gilles nevez
Phone 02 98 14 51 02
Email gilles.nevez@chu-brest.fr
Status Not yet recruiting
Phase
Start date July 25, 2022
Completion date July 25, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT00838357 - A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma). Phase 3
Terminated NCT00778856 - Hand Transplantation for the Reconstruction of Below the Elbow Amputations N/A
Active, not recruiting NCT00166842 - Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets Phase 4
Recruiting NCT04257747 - Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI N/A
Completed NCT02560909 - Adjuvanted Influenza Vaccine in Stem Cell Transplant Phase 4
Active, not recruiting NCT01687192 - Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy. Phase 2
Completed NCT00951977 - Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study N/A
Completed NCT00384137 - A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients Phase 3
Completed NCT00384202 - A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients Phase 3
Completed NCT00235664 - Prospective Study of Drug Resistant Pathogens Among Liver, Intestinal and Multivisceral Transplant Recipients N/A
Completed NCT03533049 - mHealth Family Self-Management N/A
Completed NCT02826213 - Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient
Completed NCT00170170 - Risk Factors for Cytomegalovirus Disease in Solid Organ Transplantation N/A
Recruiting NCT06367244 - Transplant Wellness Program N/A
Recruiting NCT06166186 - Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy N/A
Recruiting NCT00493194 - Fibrosis in Renal Allografts Phase 4
Completed NCT00297310 - Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation Phase 4
Completed NCT01019811 - Innervated Sensory Cross-Finger Flap N/A
Completed NCT04376775 - Assessment of the Impact of COVID-19 on Transplant Patients and on Patients Awaiting Transplantation
Active, not recruiting NCT00166816 - The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients Phase 4