Health Condition 1: Z162- Resistance to other antibiotics
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| To evaluate percentage of patients with microbiological response to CMS therapyTimepoint: time frame up to 14 days | — |
Countries
India
Contacts
All India Institute of Medical Sciences(AIIMS) Raipur