Impact of pyelonephritis on the activity of renal drug transporters in pregnant women.

Phase 4

Recruiting

• Conditions: Pyelonephritis; G03.787

• Registration Number: RBR-4npsyxz
• Lead Sponsor: Faculdade de Ciências Farmacêuticas de Ribeirão Preto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-10
• Last Update Posted: 29 May 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Pregnant women over the age of 18 will be investigated, diagnosed with pyelonephritis and with indication for treatment with antibiotics, seen at HC-FMRPUSP. Additionally, healthy pregnant patients will be recruited at the Women's Health of Ribeirão Preto-Mater (CRSMRP-Mater) and in the following basic units of health and municipal community medical centers Centro Médico Social Comunitário Vila Lobato; CSE Ipiranga / Dr Edgard Aché; UBS Dom Mielle / Prof. Dr. Aymar Baptista Prado; UBS Jardim Presidente Dutra / Dr. Sérgio Botelho da Costa Moares; USD Maria Casagrande Lopes / Ernesto Che Guevara; USF Vila Albertina / Dr. Álvaro Panazzolo; UBS Vila Tibério / Wilma Delphina by O. Garotti; UBS Bonfim Paulista / Mamoro Kobayashi and UBS Santa Cruz / Helio Lourenço de Oliveira and healthy non-pregnant volunteers from the Campus of the University of São Paulo, Campus of Ribeirão Preto. Pregnant patients of both protocols will be included in the study during the second and third quarters of the gestation

Exclusion Criteria

Pregnant women diagnosed with pyelonephritis will be excluded from the study when
present at least one of the following diseases: chronic renal failure, syndromes
hypertensive (chronic arterial hypertension and / or pre-eclampsia), chronic fetal distress and systemic lupus erythematosus. Healthy pregnant women and healthy non-pregnant volunteers will be excluded from the protocol when using OAT-inhibiting / inducing drugs, which may interact with furosemide or probenecid: amino salicylic acid, para-aminohipuric acid, citalopram, cholestyramine, escitalopram, diclofenac, digoxin , lithium, linezolid,
rifampin, rifabutin, rifapentin, sertraline and teriflunomide.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In the group of pregnant women diagnosed with pyelonephritis, it is expected to find a difference between phases of at least 30% in the parameter area under the plasma concentration versus time curve of furosemide. On healthy pregnant women group, is expected to find a difference between phases of at least 50% in the area parameter under a furosemide plasma concentration versus time curve. On healthy non-pregnant women is expected to obtain the pharmacokinetic parameter area under a plasma concentration versus time curve of furosemide in this population for comparison with the pregnant groups.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected.