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NCT04867135
Population Pharmacokinetics of Amikacin in Neonates
trial testing Amikacin Sulfate Injection in Neonatal Sepsis, Late-Onset in 138 participants. Completed in 3 September 2021.
31 July 2021
Quick facts
| Lead sponsor | Pontificia Universidad Catolica de Chile |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 138 |
| Start date | 1 December 2019 |
| Primary completion | 31 July 2021 |
| Estimated completion | 3 September 2021 |
| Sites | 1 location across Chile |
Drugs / interventions tested
- Amikacin Sulfate Injection
Conditions studied
- Neonatal Sepsis, Late-Onset — all drugs for Neonatal Sepsis, Late-Onset →
Sponsor
Pontificia Universidad Catolica de Chile — full company profile →
Who can join
Adults 3 Days to 1 Month, any sex, with Neonatal Sepsis, Late-Onset. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Aminoglycosides such as Amikacin are routinely used in newborns for the treatment of neonatal sepsis due to gram-negative bacilli. Despite the frequency of this indication, it has not yet been possible to establish definitive dosage schedules that ensure effectiveness and low risk of toxicity, due to the high pharmacokinetic variability observed in this population. In addition to anthropometric variables, evidence from retrospective studies suggests that sepsis could be capable of significantly modifying the pharmacokinetics of aminoglycosides in neonates, but the investigators suggest conducting prospective studies of higher methodological quality to verify this hypothesis. Due to the lack of pharmacokinetic and pharmacodynamic (PK / PD) studies of Amikacin in this group of patients, the investigators have raised the need to develop a prospective observational study; describing a PK / PD model of amikacin in newborns with suspected sepsis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04867135
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neonatal Sepsis, Late-Onset
Currently open trials in the same condition.
- NCT07248761 — Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Tri · Phase 4 · active not recruiting
- NCT07152106 — Amniotic Fluid & the Preterm Gut · recruiting
Other Pontificia Universidad Catolica de Chile trials
Trials by the same sponsor.
- NCT07396129 — Assessing the Efficacy of a High-Dose Lidocaine-Tetracaine Cream for the Treatment of Peripheral Neuropathic Pain · Phase 1, PHASE2 · not yet recruiting
- NCT07510425 — Artificial Intelligence vs. Automated Messaging for Continuous Regional Analgesia Follow-up · NA · not yet recruiting
- NCT07380451 — Modular Intervention for Depression Study · NA · not yet recruiting
- NCT07324499 — Effect of Dexamethasone on Plasma Levels of Bupivacaine and Dexamethasone After a Single-injection Interscalene Nerve Bl · NA · not yet recruiting
- NCT07330947 — Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery · not yet 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 NCT04867135 (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 Pontificia Universidad Catolica de Chile
- Last refreshed: 7 April 2022
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/NCT04867135.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing