Evaluation of the Effect of Oral fosfomycin Addition on Treatment of Patients with Klebsiella pneumoniae Carbapnemase Infections with Colistin

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191104045328N1

Enrollment

Registered

2019-11-10

Start date

2019-12-11

Completion date

Unknown

Last updated

2019-12-17

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

Conditions

Klebsiella pneumoniae Carbapnemase Infections. Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere

Interventions

Intervention 1: Intervention group: In the first 7 days of treatment, 31 patients will receive colistin (3 million units of TDS injectable colistin) along with oral fosfomycin (3 g per 12-hour dose).

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with Klebsiella Pneumoniae Carbapenemase infection diagnosed by reliable culture and admitted to the infectious ward of Vali Asr Hospital are studied.

Exclusion criteria

Exclusion criteria: Allergy to fosfomycin Patients with renal failure Hemodialysis Patients Under 12 years age Patients who have received antibiotics affecting KPC for the past 72 hours.

Design outcomes

Primary

Measure	Time frame
Leukocytosis. Timepoint: After a week of treatment. Method of measurement: Blood cell count.;Mute the fever. Timepoint: 24 hours / 48 hours / 72 hours / 96 hours / over 96 hours from start of treatment. Method of measurement: Using mercury thermometer orally or axillary.;Symptoms Remedy. Timepoint: 24 hours / 48 hours / 72 hours / 96 hours / over 96 hours from start of treatment. Method of measurement: Asking about the patient and the patient's status by observation.;Negative urine culture. Timepoint: After 72 hours of treatment. Method of measurement: urine culture test.	—

Measure

Time frame

Leukocytosis. Timepoint: After a week of treatment. Method of measurement: Blood cell count.;Mute the fever. Timepoint: 24 hours / 48 hours / 72 hours / 96 hours / over 96 hours from start of treatment. Method of measurement: Using mercury thermometer orally or axillary.;Symptoms Remedy. Timepoint: 24 hours / 48 hours / 72 hours / 96 hours / over 96 hours from start of treatment. Method of measurement: Asking about the patient and the patient's status by observation.;Negative urine culture. Timepoint: After 72 hours of treatment. Method of measurement: urine culture test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr hosein sarmadian

Arak University of Medical Sciences

hosseinsarmadian2015@yahoo.com+98 86 3222 2003

Outcome results

None listed

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