Leptospirosis
Conditions
Keywords
N-acetylcysteine, NAC, acute kidney injury, kidney tubular injury, oxidative stress, inflammation, KIM-1, reactive oxygen species, C-reactive protein
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.
Interventions
DRUGN-acetylcysteine
Participants received oral N-acetylcysteine 800 mg three times daily for 5 consecutive days.
DRUGPlacebo
Participants received an oral matching placebo three times daily for 5 consecutive days.
Sponsors
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Triple
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Kidney Injury Molecule-1 (KIM-1) Level From Day 1 to Day 5 | 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 | 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. |
Countries
Indonesia
Outcome results
None listed