Clinical trial • Phase IV • Gastroenterology

Ampicillin for Acute non-complicated appendicitis

Phase IV trial of Ampicillin for Acute non-complicated appendicitis. 60 participants.

Overview

Phase IV trial across 1 site in Latvia.

Recruits 60 paediatric patients.

Pregnancy Exclusion: Positive pregnancy test
Vulnerable Population: Children aged 7-18 are included and 'isVulnerablePopulationSelected' is true; subject information and informed consent form documents are provided (Pacienta informeta piekrisana_LV_Timurs_Zurmutai1 and Pacienta informeta piekrisana_RU_Timurs_Zurmutai). Specific parental consent or child assent procedures are not explicitly described in the available record.

{"criterion_text":"- Age: 7-18 years\n- Dg. Primary acute non-complicated appendicitis\n- ALVORADO score ≥ 7\n- Pain in right lower quadrant of abdomen\n- Blood tests: C-reactive protein ≤ 10 mg/L\n- *If performed: *Il-6 ≤ 39,2 pg/mL\n- *Ultrasound - acute appendicitis signs"}

{"criterion_text":"- Positive pregnancy test\n- Diffuse peritonitis\n- Previous abdominal surgery\n- Use of antibiotic drugs in previous 7 days\n- Inflammatory bowel disease\n- Immunosuppresive condition"}

{"endpoint_text":"- 3 days in-patient treatment; 7 days out-patient treatment","definition_or_measurement_approach":"Measured as duration of in-patient treatment (3 days) and out-patient treatment (7 days) as stated in endpoint text."}

{"endpoint_text":"- 1 month follow-up; 1 year follow-up","definition_or_measurement_approach":"Follow-up assessments scheduled at 1 month and 1 year."}

Planned Sample Size: 60
Recruitment Window Months: 60
Consent Approach: Subject information and informed consent form documents are provided; forms available in Latvian and Russian (Pacienta informeta piekrisana_LV_Timurs_Zurmutai1, Pacienta informeta piekrisana_RU_Timurs_Zurmutai). Specific details on who provides consent (e.g., parental consent, child assent) and languages beyond LV/RU are not explicitly detailed in the available record.

Investigational Product Name: Pamecil 1 g pulveris injekciju/infūziju šķīduma pagatavošanai
Active Substance: Ampicillin
Modality: Small molecule
Routes Of Administration: INTRAVENOUS USE
Route: Intravenous
Authorisation Status: Authorised (marketing authorisation 98-0048, LV)
Maximum Dose: 8000 mg/day (max total 24000 mg)

Investigational Product Name: Metronidazole Unifarma 5 mg/ml šķidums infūzijām
Active Substance: Metronidazole
Modality: Small molecule
Routes Of Administration: INTRAVENOUS USE
Route: Intravenous
Authorisation Status: Authorised (marketing authorisation 05-0168, LV)
Maximum Dose: 1500 mg/day (max total 4500 mg)

Investigational Product Name: Ceftazidime Fresenius Kabi 1000 mg pulveris injekciju šķīduma pagatavošanai
Active Substance: Ceftazidime pentahydrate
Modality: Small molecule
Routes Of Administration: INTRAVENOUS USE
Route: Intravenous
Authorisation Status: Authorised (marketing authorisation 08-0388, LV)
Maximum Dose: 3000 mg/day (max total 9000 mg)

Other published trials that may interest you.