NCT06122311

Brief Summary

When treating individuals with febrile neutropenia, amphotericin B (AmB-d) is one of the most effective treatments against often fatal systemic fungal infections.Nephrotoxicity from amphotericin B can develop with an incidence of up to 80.This emphasizes the value of nephroprotectant agent use.Because of N-acetylcysteine's antioxidant, antiapoptotic, vasodilator properties and its therapeutic effects on contrast nephropathy. Acetylcysteine's impact on amphotericin B-induced nephrotoxicity in cancer patients is assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

November 1, 2023

Last Update Submit

July 3, 2024

Conditions

Drug-Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

  • incidence of nephrotoxicity

    minimum of 0.3 mg/dL increase in serum creatinine within 48 hours from amphotericin B initiation.

    During the intervention

Secondary Outcomes (1)

  • electrolyte imbalances

    During the intervention

Other Outcomes (2)

  • cost effectiveness analysis

    From start of amphotericin b to discharge or death ,whichever came first or up to 120 days

  • length of hospital stay(days)

    From start of amphotericin b to discharge or death ,whichever came first or up to 120 days

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

amphotericin b (0.5-1.25 mg/kg )over 6-8 hours +NAC 600mg twice daily throughout amphotericin b treatment

Drug: N Acetylcysteine

amphotericin b

NO INTERVENTION

amphotericin b (0.5-1.25mg/kg)over 6-8 hours infusion

Interventions

N AcetylcysteineDRUG

N-acetylcysteine sachets 600 mg twice daily

Also known as: Acetylcysteine
N-acetylcysteine

Eligibility Criteria

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

You may qualify if:

  • Age more than 18 years.
  • Patients who have indication for systemic (injection) for conventional amphotericin at least 7 days.

You may not qualify if:

  • documented acute kidney injury defined by an increase in serum creatinine ‡ 0.3 mg/dl within 48 h, or an increase in serum creatinine by ‡ 1.5 times baseline within the prior 7 days, or urine volume \<0.5 ml/kg/h for 6 h
  • documented chronic kidney disease (clearance creatinine below 60 ml/min/1.73 m2 calculated by the abbreviated Modification of Diet in Renal Disease equation), history of peritoneal or hemodialysis for \> 3 months
  • sepsis
  • Severe hemorrhage(Blood loss \> 3 litres)
  • Patient with cardiac or chronic liver disease history of receiving AmB by any administration route within the recent 14 days known allergy to either amphotericin b or N-acetylcysteine.
  • receiving any formulation of NAC within the last week.
  • unable to tolerate oral intake.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helwan University

Cairo, Egypt

Location

Related Publications (4)

  • Karimzadeh I, Khalili H, Sagheb MM, Farsaei S. A double-blinded, placebo-controlled, multicenter clinical trial of N-acetylcysteine for preventing amphotericin B-induced nephrotoxicity. Expert Opin Drug Metab Toxicol. 2015;11(9):1345-55. doi: 10.1517/17425255.2015.1042363. Epub 2015 Jun 11.

    PMID: 26050706BACKGROUND

  • Odabasi Z, Karaalp A, Cermik H, Mohr J, Tigen ET, Koc M, Korten V. Reduction of amphotericin B-induced renal tubular apoptosis by N-acetylcysteine. Antimicrob Agents Chemother. 2009 Jul;53(7):3100-2. doi: 10.1128/AAC.00001-09. Epub 2009 May 4.

    PMID: 19414577BACKGROUND

  • Feldman L, Efrati S, Dishy V, Katchko L, Berman S, Averbukh M, Aladjem M, Averbukh Z, Weissgarten J. N-acetylcysteine ameliorates amphotericin-induced nephropathy in rats. Nephron Physiol. 2005;99(1):p23-7. doi: 10.1159/000081799.

    PMID: 15637469BACKGROUND

  • Ebid AIM, Mohamed HS, Mohammed YMM, Mohamed Abdel Motaleb SM. Efficacy, Safety, and Cost-Effectiveness of N-Acetylcysteine in Preventing Amphotericin B Nephrotoxicity in Egyptian Patients with Hematological Malignancies: A Randomized Controlled Trial. Hosp Pharm. 2025 May 6:00185787251337615. doi: 10.1177/00185787251337615. Online ahead of print.

    PMID: 40342610DERIVED

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • yasmin munir, master

    Helwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 8, 2023

Study Start

August 25, 2023

Primary Completion

June 10, 2024

Study Completion

June 10, 2024

Last Updated

July 5, 2024

Record last verified: 2024-07

Locations

EG(1)