N-Acetylcysteine in Patients With Leptospirosis

NCT07821853 | Completed Phase 2

• 1 other identifier: 25-08-1192
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether oral N-acetylcysteine (NAC) can reduce markers of kidney tubular injury, oxidative stress, and inflammation in adults with non-severe leptospirosis. The main questions it aims to answer are:

• Does NAC result in a greater reduction in urinary kidney injury molecule-1 (KIM-1) levels from Day 1 to Day 5 compared with placebo?
• Does NAC result in a greater reduction in serum reactive oxygen species (ROS) and C-reactive protein (CRP) levels from Day 1 to Day 5 compared with placebo? Researchers will compare NAC with a placebo to determine whether NAC produces greater changes in these biomarkers. Participants will:
• Receive oral NAC 800 mg three times daily or a matching placebo for five days in addition to standard treatment for leptospirosis.
• Have urinary KIM-1, serum ROS, and CRP measured before treatment and on Day 5.

Conditions

Leptospirosis

Keywords

N-acetylcysteine; NAC; acute kidney injury; kidney tubular injury; oxidative stress; inflammation; KIM-1; reactive oxygen species; C-reactive protein

Outcome Measures

Primary Outcomes (2)

• Change in Urinary Kidney Injury Molecule-1 (KIM-1) Level From Day 1 to Day 5

  Change in urinary KIM-1 concentration from before treatment (Day 1) to Day 5, compared between the N-acetylcysteine and placebo groups.

  Day 1 to Day 5

• Change in Serum Reactive Oxygen Species (ROS) Level From Day 1 to Day 5

  Change in serum reactive oxygen species (ROS) concentration from before treatment (Day 1) to Day 5, compared between the N-acetylcysteine and placebo groups.

  Day 1 to Day 5

Study Arms (2)

Arm 1

EXPERIMENTAL

N-acetylcysteine

Drug: N-acetylcysteine

Arm 2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Placebo DRUG

Participants received an oral matching placebo three times daily for 5 consecutive days.

Arm 2

N-acetylcysteine DRUG

Participants received oral N-acetylcysteine 800 mg three times daily for 5 consecutive days.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Fever onset on Day 3 to Day 5.
• Non-severe leptospirosis (mild to moderate) according to WHO classification, confirmed serologically by a positive Leptospira IgM ELISA test.
• No history of chronic kidney disease based on medical history, medical records, or kidney function assessment before the leptospirosis episode.
• Willing to participate in the study and provide written informed consent.
• No previous N-acetylcysteine therapy before randomization.

You may not qualify if:

• Severe leptospirosis or Weil's disease according to WHO classification.
• Chronic kidney disease stage G3-G5 according to KDIGO classification.
• Diabetes mellitus with diabetic nephropathy.
• Uncontrolled or malignant hypertension.
• Glomerulonephritis or other immunologic kidney disease.
• Current use of potentially nephrotoxic medications, including aminoglycosides, non-steroidal anti-inflammatory drugs, chemotherapeutic agents, or other nephrotoxic drugs.
• Severe chronic liver disease.
• Severe heart disease or severe circulatory disorder.
• Severe chronic pulmonary disease, including severe chronic obstructive pulmonary disease or uncontrolled persistent severe asthma.
• Gastrointestinal disorders that may impair oral N-acetylcysteine absorption, including ileus, persistent vomiting, or severe malabsorption.
• Pregnancy or breastfeeding.
• History of hypersensitivity to N-acetylcysteine.
• Refusal to participate or withdrawal of informed consent.

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

RSUD Balaraja

Tangerang, Banten, 15610, Indonesia

Location

MeSH Terms

Conditions

Leptospirosis; Acute Kidney Injury; Inflammation

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology and Hypertension Trainee, Internist, Department of Internal Medicine, Principal Investigator

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 16, 2026
• Study Start: August 30, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 26, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

ID (1)