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Colistin loading dose in pediatrics

Comparing efficacy and safety of Colistin Loading dose regimen versus Conventional regimen in improving clinical and microbiological response for the treatment of multidrug resistant gram-negative infections in pediatrics

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170614034532N2
Enrollment
40
Registered
2018-06-11
Start date
2018-07-23
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

Condition 1: bloodstream infections. Condition 2: Ventilator Associated Pneumonia.

Interventions

Intervention 1: Intervention group: Patients receive a loading dose of 150,000 IU/Kg.The loading dose is followed by 50,000 IU every 8 hours. Clinical, microbiological and laboratory findings are coll

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 18 Years

Inclusion criteria

Inclusion criteria: Colistin receiving for at least four days Normal baseline renal status before administration of Colistin Children from 1 month to 18 years Children with a positive blood culture or VAP Gram negative culture which is only susceptible to Colistin

Exclusion criteria

Exclusion criteria: Parents Dissatisfaction Receiving Nebulized form of Colistin for VAP Receiving antibiotics effective on gram negative micro organisms other than Colistin and Meropenem

Design outcomes

Primary

MeasureTime frame
Clinical response. Timepoint: at the beginning of the study (before starting the intervention) and 72 hours after the start of treatment. Method of measurement: Laboratory data.;Microbiological response. Timepoint: at the beginning of the study (before starting the intervention) and 72 hours after the start of treatment. Method of measurement: Microbial culture.

Secondary

MeasureTime frame
The prevalence and severity of Nephrotoxicity. Timepoint: 72hrs after starting Colistin. Method of measurement: Laboratory data; Measurement of Urine Volume.;The prevalence of Neurotoxicity. Timepoint: 72hrs after starting Colistin. Method of measurement: Clinical outcomes.;The prevalence of Colistin resistance. Timepoint: 72hrs after starting Colistin. Method of measurement: Microbial culture.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShiva Fatehi

Tehran University of Medical Sciences

shiva.fatehi@yahoo.com+98 21 6690 1887

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026