Clinical efficacy and pharmacokinetics of colistimethate sodium in pediatric patients.

Not Applicable

• Conditions: Health Condition 1: Z162- Resistance to other antibiotics

• Registration Number: CTRI/2023/04/051382
• Lead Sponsor: AIIMS RAIPUR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

1.Patients with average body weight < 4.55kg.

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 < 48 hrs.

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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