NCT07668141

Brief Summary

Nephrotoxicity is a great concern in patients receiving intravenous colistin and there is a disparity in the reported rates between previous studies. Several preclinical researches studied the effect of the antioxidants (e.g. L.carnitine, vitamin C, vitamin E, N-acetyl cysteine, and alpha lipoic acid) in reducing the risk of colistin-induced nephrotoxicity but there is a lack of clinical studies on human. Due to the paucity of studies that early predict colistin-induced nephrotoxicity using early acute kidney injury "AKI" biomarkers e.g. kidney injury molecule 1"KIM1" and the lack of human studies that evaluate the role of alpha lipoic acid in ameliorating colistin-induced nephrotoxicity, so this study will be conducted.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at below P25 for phase_3

Timeline
7mo left

Started Jun 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Jun 2026Feb 2027

First Submitted

Initial submission to the registry

June 12, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 12, 2026

Last Update Submit

June 19, 2026

Conditions

Nephrotoxicity

Keywords

colistinAlpa lipoic acidkidney injury molecule-1Nephrotoxicity

Outcome Measures

Primary Outcomes (1)

  • Change in urinary kidney injury molecule-1 (KIM-1)

    Urinary KIM-1 will be measured at baseline and on Day 5 of treatment in patients receiving colistin alone or colistin plus alpha-lipoic acid.

    Baseline to Day 5

Secondary Outcomes (1)

  • Time to Development of Acute Kidney Injury

    From randomization until the first occurrence of acute kidney injury, hospital discharge, death from any cause, or colistin discontinuation, whichever occurs first, assessed up to 30 days.

Study Arms (2)

Control group

NO INTERVENTION

this group receives only intravenous colistin therapy

alpha lipoic acid group

ACTIVE COMPARATOR

this group receives oral alpha lipoic acid in addition to intravenous colistin therapy

Drug: alpha lipoic acid drug (thioctic acid acid)

Interventions

alpha lipoic acid drug (thioctic acid acid)DRUG

Oral alpha-lipoic acid will be administered at the start of colistin therapy till the end of the colistin course by a dose of 600 mg every 8 hours to be taken 30 min before meals in the intervention group.

alpha lipoic acid group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients who receive intravenous colistin and had positive cultures of multidrug resistant gram negative bacteria.
  • Patients who receive colistin for at least 3 days during their treatment.

You may not qualify if:

  • Patients who receive inhaled colistin.
  • Patients who had AKI at baseline
  • chronic kidney disease patients on regular hemodialysis.
  • Renal transplant patients
  • Concurrent use of other nephrotoxic drugs e.g. vancomycin, gentamicin, amikacin and amphotericin B.
  • Concurrent use of other antioxidants e.g. vitamin C, vitamin E and N-acetyl cysteine.
  • Patients are not willing to participate in the study.
  • Patients with any missed doses of colistin and or alpha-lipoic acid.
  • Patients with incomplete medical data
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

6th October Hospital-Dokki-General Authority for Health Insurance Organization

Giza, Egypt

Location

Al-Haram Hospital

Giza, Egypt

Location

Related Links

MeSH Terms

Interventions

Thioctic Acid

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Eman Magdy Elsayed Elyamany, Assistant lecturer

    Faculty of pharmacy-Helwan university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Magy Elsayed Elyamany, Assistant lecturer

CONTACT

+201121051356Iman.elyamany@pharm.capu.edu.eg

Mahmoud Ibrahim Mostafa, Lecturer

CONTACT

+201006605563mahmoud.ibrahim@pharm.capu.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at pharmacy practice department

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 25, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared to protect participant confidentiality.

Locations

EG(2)