The Norwegian Antibiotics for Pneumonia in Children (NAPIC) Study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512001-39-01

Acronym

NAPIC

Enrollment

500

Registered

2024-12-10

Start date

2018-02-01

Completion date

Unknown

Last updated

2024-12-10

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

Conditions

Lower respiratory tract infection

Brief summary

Determined by 21 days after treatment start as: Therapy failure

Detailed description

Therapy failure leading to intravenous antibiotic therapy, Duration of fever, Duration of symptoms, assessed by parent/guardian, Bacterial presence in airways, Presence of resistant bacteria, Resistance genes (bacteria)

Interventions

DRUGINFECTOMOX® 500 Saft 500 mg/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen

DRUGPlacebo for IMP including Amylum solani Sugar Titandioksyd Silica colloid.anhydr. Sodium citrate Acid. citric Mg-stearas Strawberry aroma Raspberry aroma Xantan gum Gentiana lutea

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Determined by 21 days after treatment start as: Therapy failure	—

Secondary

Measure	Time frame
Therapy failure leading to intravenous antibiotic therapy, Duration of fever, Duration of symptoms, assessed by parent/guardian, Bacterial presence in airways, Presence of resistant bacteria, Resistance genes (bacteria)	—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026