Acetaminophen in Combination With N-Acetylcysteine (NAC) Versus Placebo in Treating Fever

Columbia University

Status: Withdrawn

Conditions: Fever; Prevention & Control; Drug Induced Liver Injury; Liver Failure; Liver Failure, Acute

Treatments: Drug: APAP and NAC combination; Drug: APAP and Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01137591

AAAD4090

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of the an N-acetyl-p-aminophenol (APAP, also known as acetaminophen) and N-acetylcysteine (NAC) combination versus an APAP-placebo combination as an anti-pyretic agent.

Full description

N-acetyl-p-aminophenol (APAP), or more commonly known as acetaminophen in the United States, accounts for more overdose and overdose deaths in the United States and United Kingdom than any other pharmaceutical agent. If N-acetylcysteine (NAC) is given within 8 to 10 hours of APAP ingestion, it has been shown to prevent serious liver failure and death in the setting of overdoses. Therefore, it may be beneficial to administer APAP in combination with NAC routinely to reduce rates of liver failure and death. Because NAC's main role is to reduce the accumulation of APAP's toxic metabolites, the concomitant administration of NAC should have no impact on the efficacy of APAP as an antipyretic and analgesic. Thus, we propose a single-center, non-inferiority randomized control study comparing the efficacy of the APAP-NAC combination as compared to APAP-placebo as an anti-pyretic agent.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults aged 18 to 75 years old
• admitted to an inpatient unit at Columbia-Presbyterian Medical Center
• fever defined as an oral temperature of 38.5°C

Exclusion criteria

• if oral temperature cannot be obtained
• abnormal aminotransferase levels
• prior adverse reaction to acetaminophen or N-acetylcysteine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

APAP and NAC combination

Experimental group

Description:

N-acetyl-p-aminophenol and placebo (APAP-NAC) combination pill

Treatment:

Drug: APAP and NAC combination

APAP and Placebo combination

Placebo Comparator group

Description:

N-acetyl-p-aminophenol and placebo (APAP-placebo) combination pill

Treatment:

Drug: APAP and Placebo