LeptospirosisPhase 2NCT07821853
N-Acetylcysteine in Patients With Leptospirosis
A Phase 2 study testing N-acetylcysteine in people with Leptospirosis, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptospirosis
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Aug 2025to 26 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efek N-Acetylcysteine Terhadap Cedera Tubulus Ginjal, Stres Oksidatif, Dan Inflamasi Pada Pasien Leptospirosis Non-Severe: Sebuah Uji Klinis Acak Tersamar Ganda
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?
Read more
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
- Being tested
- N-acetylcysteine, Placebo
- Keywords
- N-acetylcysteine, NAC, acute kidney injury, kidney tubular injury, oxidative stress, inflammation, KIM-1, reactive oxygen species, C-reactive protein
- Medical subject headings
- Leptospirosis, Acute Kidney Injury, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Participants received oral N-acetylcysteine 800 mg three times daily for 5 consecutive days.
PlaceboDrug
Participants received an oral matching placebo three times daily for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | N-acetylcysteine Receives: Drug: N-acetylcysteine |
| Arm 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start30 Aug 2025
- Primary completion1 Apr 2026
- Study completion26 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeptospirosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selfie C. Rijal, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821853
- Sponsor's protocol ID
- 25-08-1192
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efek N-Acetylcysteine Terhadap Cedera Tubulus Ginjal, Stres Oksidatif, Dan Inflamasi Pada Pasien Leptospirosis Non-Severe: Sebuah Uji Klinis Acak Tersamar Ganda
- ClinicalTrials.gov ID
- NCT07821853
- Acronym / sponsor ID
- 25-08-1192
- Conditions
- Leptospirosis
- Keywords
- N-acetylcysteine, NAC, acute kidney injury, kidney tubular injury, oxidative stress, inflammation, KIM-1, reactive oxygen species
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 26 Apr 2026 (actual)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: N-acetylcysteineN-acetylcysteine |
| Arm 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineParticipants received oral N-acetylcysteine 800 mg three times daily for 5 consecutive days. | Drug | Arm 1 |
| PlaceboParticipants received an oral matching placebo three times daily for 5 consecutive days. | Drug | Arm 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine in people with Leptospirosis, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary Kidney Injury Molecule-1 (KIM-1) Level From Day 1 to Day 5 (time frame: Day 1 to Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.