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

Pyelonephritis impacts on organic anion transporters (OAT) 1 and 3 activity in pregnant women: a quantitative system pharmacology approach

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-4npsyxz
Enrollment
Unknown
Registered
2021-10-10
Start date
2019-09-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyelonephritis

Interventions

Group 1: Pregnant patients diagnosed with pyelonephritis with indication for treatment with intravenous antibiotics (e.v.), according to the clinical protocol of the local hospital (cefuroxime 750 mg
D02.065.884.725.300

Sponsors

Faculdade de Ciências Farmacêuticas de Ribeirão Preto
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactJhohann Benzi
jhohann_benzi@yahoo.com+55-16-997731926

Outcome results

None listed

Source: REBEC (via WHO ICTRP)