N-Acetylcysteine in Patients With Leptospirosis

Dr Cipto Mangunkusumo General Hospital64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Leptospirosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.