N-AcetylCysteine as anti-oxidative treatment in severe malaria

A randomised, double-blind, placebo-controlled trial of N-AcetylCysteine as adjunctive therapy in the treatment of severe falciparum malaria

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN20156397

Enrollment

100

Registered

2005-10-14

Start date

2004-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falciparum malaria Infections and Infestations Malaria

Interventions

This will be a randomised, double-blind, placebo-controlled trial of the efficacy and safety of N-acetylcysteine in the adjunctive treatment of severe falciparum malaria, enrolling 100 patients. Anti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults patients (more than or equal to 16 years old, either sex) with a diagnosis of severe malaria: asexual Plasmodium falciparum parasitaemia with one or more of the following criteria: 1. Glasgow coma scale less than 11 2. Haematocrit less than 20% with parasite count more than 100,000/mm^3 3. Jaundice with bilirubin more than 2.5 mg/dl with parasite count more than 100,000/mm^3 4. Serum creatinine more than 3 mg/dl with urine less than 400 ml/24 hours 5. Hypoglycaemia with venous glucose more than 40 mg/dl 6. Systolic blood pressure less than 80 mmHg with cool extremeties 7. Peripheral asexual stage parasitaemia more than 10% 8. Peripheral venous lactate more than 4 mmol/l 9. Peripheral venous bicarbonate less than 15 mmol/l

Exclusion criteria

Exclusion criteria: 1. Inability or unwillingness to give informed consent by patient or attendant relatives 2. Pregnancy or breast feeding. A pregnancy test will be performed on indication 3. Known hypersensitivity to NAC 4. History of asthma or wheeze detected on auscultation on admission 5. Previous treatment with lactate containing intravenous fluid (e.g. Ringer?s Lactate Solution)

Design outcomes

Primary

Measure	Time frame
1. Serial plasma lactate, glucose, serum creatinine, bilirubin and acid-base status 2. Serial Glasgow Coma Score (GCS) and vital signs 3. Parasite clearance time 4. Adverse events	—

Secondary

Measure	Time frame
1. Serial red cell deformability 2. Serial observation of the microcirculation on the mucosal surface using a non-invasive method, Orthogonal Polarising Spectrometry (Groner et al, 1999) 3. Serial plasma cytokine (Interleukin [IL]-6, 8, 10 and Tumour Necrotising Factor [TNF]) concentrations and measures of oxidative stress (F2-isoprostanes) 4. Mortality	—

Countries

Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026