N-Acetylcysteine in Patients With Leptospirosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

RSUD Balaraja

Tangerang, Banten, 15610, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

N-acetylcysteine

Drug

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

Placebo

Drug

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

Primary outcomes

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

Time frame: 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.
Change in Serum Reactive Oxygen Species (ROS) Level From Day 1 to Day 5

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Registry information

Official study title

Efek N-Acetylcysteine Terhadap Cedera Tubulus Ginjal, Stres Oksidatif, Dan Inflamasi Pada Pasien Leptospirosis Non-Severe: Sebuah Uji Klinis Acak Tersamar Ganda

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 16, 2026
Registry last updated: Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not yet recruiting