Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
500
Countries
1
Sites
9
Lower respiratory tract infection
Determine the effect of amoxicillin versus placebo in preschool children with pneumonia.
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 1 Feb 2018 → ongoing
- Decision date (initial)
- 2024-12-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Clinical therapy research in the specialist health services,South-Eastern Norway Regional Health Au
External identifiers
- EU CT number
- 2024-512001-39-01
- EudraCT number
- 2017-003791-31
- ClinicalTrials.gov
- NCT20171863
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Determine the effect of amoxicillin versus placebo in preschool children with pneumonia.
Secondary objectives 2
- Influence of amoxicillin on bacterial flora in airways
- Subgroup analyses: by findings on chest x-ray, the presence of specific bacteria/virus and the rates of inflammatory markers.
Conditions and MedDRA coding
Lower respiratory tract infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10010120 | Community acquired pneumonia | 10021881 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-512001-39-00 | The Norwegian Antibiotics for Pneumonia in Children (NAPIC) Study | Oslo University Hospital HF |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age 12-59 months
- Fever. Temperature ≥38.0 at inclusion or reported within the last 24 hours
- Tachypnoe, age specific
- ≥1 sign of lower airway inflammation; Cough (at inclusion or reported within the last 6 hours), Chest retractions (jugular, intercostally or subcoastally), grunting respiration, nasal flaring, crepitations by pulmonary auscultation, hypoxia (SpO2 ≤90%)
- Weight between 6.0 and 28.0 kg
Exclusion criteria 7
- Clinical suspicion of bacterial pneumonia based upon a temperature ≥39.0 C and at least one of the following: bronchial breathing sounds, unilaterally decreased breth sounds or unilateral percussion dullness, pulmonary lobar consilidation and/or radiological suspicion of empyema on chest x-ray if this is obtained prior to inclusion in the trial.
- Evidence of any bacterial infection requiring systemic antibiotics, including, but not exclusively: clinical septicaemia, urinary tract infection, meningitis
- Systemic antibiotics received within the last 7 days
- History of ant serious underlying disease including: haematolocigal or oncological: immunodeficiency, congenital heart disease, neuromuscular impairment, development disorder, including Dwns syndrome, bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, poorly controlled asthma or severe chronic lung diseases
- Acute lower obstructive airways (prolonged expiration and generalised expiratory wheeze)
- Stridor (inspiratory)
- Known or suspected allergy against the investigational product or any of the constituents
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Determined by 21 days after treatment start as: Therapy failure
Secondary endpoints 6
- 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)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
INFECTOMOX® 500 Saft 500 mg/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen
PRD519282 · Product
- Active substance
- Amoxicillin Trihydrate
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL USE
- Max daily dose
- 18 ml millilitre(s)
- Max total dose
- 126 ml millilitre(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- 24657.01.01
- MA holder
- INFECTOPHARM ARZNEIMITTEL UND CONSILIUM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Håvard O. Skjerven
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Håvard O. Skjerven
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 500 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
St. Olavs Hospital HF
Pediatrics, Prinsesse Kristinas G. 3, 7030, Trondheim
Nordlandssykehuset HF
Pediatrics, Parkveien 95, 8005, Bodo
Universitetssykehuset Nord-Norge HF
Pediatrics, Sykehusvegen 38, 9019, Tromsoe
Oslo University Hospital HF
Department of pediatric allergy and pulmonary diseases, Taarnbygget, Kirkeveien 166, Oslo
Helse Moere Og Romsdal HF
Pediatrics, Aasehaugen 1, 6017, Aalesund
Sykehuset Oestfold HF Kalnes
Pediatrics, Kalnesveien 300, 1714, Graalum
Akershus University Hospital
Pediatrics, Sykehusveien 27, 1478, Lorenskog
Helse Stavanger HF
Pediatrics, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Helse Bergen HF
Pediatrics, Haukelandsveien 22, 5021, Bergen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2018-02-01 | 2018-02-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2024-512001-39-00 | 7 |
| Recruitment arrangements (for publication) | Placeholder minimum application | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF 1-5 years | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 0-5 yr AHUS | 6 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Infectomox | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ENG 2024-512001-39-00 | 7 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-12 | Norway | Acceptable 2024-12-10
|
2024-12-10 |