ClinicalTrials.gg
CompletedNCT07821853Updated Sep 16, 2026

N-Acetylcysteine in Patients With Leptospirosis

A Phase 2 interventional study of N-acetylcysteine and Placebo in Leptospirosis, sponsored by Dr Cipto Mangunkusumo General Hospital. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Dr Cipto Mangunkusumo General Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Aug 2025, registered Aug 2026).
Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Leptospirosis

Keywords

  • N-acetylcysteine
  • NAC
  • acute kidney injury
  • kidney tubular injury
  • oxidative stress
  • inflammation
  • KIM-1
  • reactive oxygen species
  • C-reactive protein
03

In context

Leptospirosis

25 studies on the registry are indexed under Leptospirosis; 11 are open to participants now.

This study's enrollment of 64 is below the median of 260 across 14 interventional studies indexed under Leptospirosis.

Browse Leptospirosis studies →

Lead sponsor

Dr Cipto Mangunkusumo General Hospital is the lead sponsor of 39 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • No previous N-acetylcysteine therapy before randomization.

Exclusion criteria

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 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 to N-acetylcysteine.
  • Refusal to participate or withdrawal of .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Arm 1

    N-acetylcysteine

    Drug: N-acetylcysteine

  • Placebo comparator
    Arm 2

    Placebo

    Drug: Placebo

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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.

    Time frame: Day 1 to Day 5

07

Study locations

1 site
  • RSUD Balaraja
    Tangerang, Banten 15610, Indonesia
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2025 to primary completion in Apr 2026, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Sep 16, 2026
StartActual
Aug 30, 2025
Primary completionActual
Apr 1, 2026
CompletionActual
Apr 26, 2026
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07821853
Lead sponsor
Dr Cipto Mangunkusumo General Hospital
Responsible party
Selfie C. Rijal (Nephrology and Hypertension Trainee, Internist, Department of Internal Medicine, Principal Investigator, Dr Cipto Mangunkusumo General Hospital) — Principal investigator
First posted
Sep 16, 2026
Start date
Aug 30, 2025
Primary completion
Apr 1, 2026
Completion
Apr 26, 2026
Last update
Sep 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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