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Clinical efficacy and pharmacokinetics of colistimethate sodium in pediatric patients.

Clinical efficacy and pharmacokinetics of colistimethate sodium in critically ill paediatric patients admitted in a tertiary care teaching hospital in India: a prospective longitudinal observational pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/04/051382
Enrollment
30
Registered
2023-04-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: Z162- Resistance to other antibiotics

Interventions

Intervention1: nil: nil

Sponsors

AIIMS RAIPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 1 months- 15 years of either sex 2. Suspected or culture proven MDR-GNB infection requiring CMS administration as per the decision of treating Paediatrician.

Exclusion criteria

Exclusion criteria: 1.Patients with average body weight 2.Patients who have received CMS before study (time frame: within last 7 days) 3.Administration of CMS through other routes (inhalational/intrathecal/intraventricular) 4.Patients with renal impairment manifested as serum creatinine above the upper limit of age ( >0.4 mg/dl for infants, >0.7 mg/dl for children, >1 mg/dl for adolescents) 5.Parental refusal of consent. 6.Cystic fibrosis 7.History of hypersensitivity to colistin 8.Family or personal history of myasthenia gravis 9.Refractory shock or other illness with an expectative life 10.Positive serology for HBV, HCV and HIV 11. Concomitant use of other nephrotoxic drugs and drugs found to interact with colistin as per FDA guidelines like aminoglycosides, polymyxin, Curariform muscle relaxants (e.g., tubocurarine) and other drugs, including ether, succinylcholine, gallamine, decamethonium, sodium citrate, Sodium cephalothin.

Design outcomes

Primary

MeasureTime frame
1) To evaluate the clinical response of CMS therapy 2) To estimate the pharmacokinetic parameters(Cmax,Cmin,Cssavg,Tmax,AUC0-12, AUC0-24, Vd) in patients receiving CMS therapy. Timepoint: At the end of 14 days(2 weeks)

Secondary

MeasureTime frame
To evaluate percentage of patients with microbiological response to CMS therapyTimepoint: time frame up to 14 days

Countries

India

Contacts

Public ContactKrishnapriya N

All India Institute of Medical Sciences(AIIMS) Raipur

drpugal23@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026