Last reviewed · How we verify
NCT05775692
Population Pharmacokinetics of Fluconazole in the Treatment of Neonatal Fungal Infectious Disease
trial testing fluconazole in Fluconazole in 150 participants. Status unknown.
31 October 2023
Quick facts
| Lead sponsor | Beijing Children's Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 1 January 2020 |
| Primary completion | 31 October 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- fluconazole (fluconazole) — full drug profile →
Conditions studied
- Fluconazole — all drugs for Fluconazole →
- Infection — all drugs for Infection →
- Newborn — all drugs for Newborn →
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
Beijing Children's Hospital
Who can join
Adults 1 Minute to 28 Days, any sex, with Fluconazole or Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is based on the hypothesis that the pharmacokinetics of fluconazole in newborns and children are different from adults. We aim to study the population pharmacokinetics of newborns and children receiving the fluconazole for treatment of infectious diseases. In this study, we will detect fluconazole concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, we also want to correlate use of fluconazole with treatment effectiveness and incidence of adverse effects in newborns and children. This novel knowledge will allow better and more rational approaches to the treatment of infectious diseases in newborns and children. It will also set the foundation for further studies to improve fluconazole therapies for newborns and children.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05775692
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of fluconazole
Trials testing the same drug.
- NCT07341672 — A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itrac · Phase 1 · not yet recruiting
- NCT06847464 — A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the P · Phase 1 · completed
- NCT05471063 — Clinical Study of ABCD in the Treatment of Cryptococcal Meningitis · NA · unknown
- NCT05076409 — A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood · Phase 1 · completed
- NCT03451110 — Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive · Phase 1 · completed
Other Beijing Children's Hospital trials
Trials by the same sponsor.
- NCT07412119 — Research on Disease Control and Mental Health Status of Adolescent Asthma Patients · not yet recruiting
- NCT06837584 — Control and Treatment of Outpatient Children With Asthma · not yet recruiting
- NCT07199101 — Multicenter Pediatric Low-Dose CT Protocol: Development and Clinical Verification · NA · not yet recruiting
- NCT07488728 — Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-A · NA · recruiting
- NCT07029958 — Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Vir · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05775692 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Children's Hospital
- Last refreshed: 20 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05775692.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing