CTRI/2021/12/038933已完成4 期
A Multicentre, Open-label, Non-comparative Phase IV Clinical Study to Evaluate the Safety and Clinical Efficacy of Augmentin Extra Strength (ES)-600 (amoxicillin/potassium clavulanate 14:1 combination) in Children with Acute Respiratory Tract Infections (ARTIs) in India
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Diagnosis of AOM on basis of otoscopic findings as defined below
- •Purulent otorrhea of less than 24 hours duration
- •OR Middle ear effusion (MEE)
- •Middle ear effusion is evidenced by at least two of the following:
- •Decreased or absent tympanic mobility measured by pneumatic otoscopy,
- •Yellow or white discoloration of the tympanic membrane, or Opacification of the tympanic membrane PLUS At least one of the following indicators of acute inflammation: Ear pain within 24 hours, including unaccustomed tugging or rubbing of ear, Marked redness of the tympanic membrane, or Distinct fullness or bulging of the tympanic membrane.
- •OR Child with ABRS with inflammation as bacterial infection who has the following symptoms/signs on the day of or the day before the first dose of the investigational product:
- •Redness of the nasal mucosa.
- •Nasal or postnasal discharge is purulent or mucopurulent. Pathological shadow in the paranasal sinus on a radiogram (only for reference-based on investigator discretion). Patient with surgical history should be excluded but patient with a pervious surgery more than 365 days before and apparently preserved maxillary sinus mucosa or patient with a previous surgery of nasal polypectomy more than 90 days before may be enrolled in the study.
- •Child with ABRS whose severity is classified as moderate or severe (total score greater than or equal to 4) based on the nasal cavity findings and symptoms as shown below.
- •Symptom: Rhinorrhoea- None: 0 Mild/Small amount : 1 Moderate or severe: 2
- •Symptom: Bad mood/ productive cough- None: 0 Mild/Small amount : 1 Moderate or severe: 2
- •Nasal cavity finding: Nasal/postnasal discharge- None: 0 (Serous) Mild/small amount: 2 (Mucopurulent, small amount) Moderate or
- •severe: 4 (Moderate or larger amount)
- •OR Child diagnosed with CABP based on following criteria: (At least three of the four criteria should be met to include in the study)
- •i. History of documented fever (rectal, ear, or oral temperature >=38°C or axillary temperature >=37.5°C) or hypothermia (rectal, ear, or oral
- •temperature <35°C or axillary temperature <34.5°C)
- •ii. Acute onset or worsening within the previous 5 days of at least two of the
- •following nine clinical signs and symptoms:
- •tachycardia, defined as follows:
- •â?ª6 months to <24 months: >=160 beats/min
- •â?ª24 months to <10 years: >=140 beats/min
- •â?ª>=10 years: >=100 beats/min
- •tachypnea, defined as follows:
- •â?ª6 months to <12 months: >=50 breaths/min
- •â?ª12 months to <5 years: >=40 breaths/min
- •â?ª>=5 years: >=20 breaths/min
- •sputum production,
- •chest pain,
- •increased work of breathing
- •iii. At least one of the five following laboratory findings:
- •leukocytosis ( >15,000 white blood cells/mm3
- •>15% immature neutrophils (bands) regardless of total peripheral
- •white blood cell (WBC),
- •leukopenia (4,500 WBC/mm3
- •iv. Presence with new infiltrates consistent with bacterial pneumonia including new alveolar or lobal infiltrate or consolidation (based on imaging result) - based on investigatorâ??s discretion only
- •3. The participant and parent(s)/legal guardian(s) are willing and able to comply
排除标准
- •Participants will be excluded from the study if they meet any of the following exclusion
- •1. Weight >= 40 kg
- •2. Pre-existing renal insufficiency (eg, plasma creatinine >1.5 times upper limit of
- •normal range for age)
- •3. Pre-existing liver disease(s) and/or hepatic dysfunction
- •4. A serious underlying disease as per clinicianâ??s judgment.
- •5. Currently having diarrhea at the time of screening
- •6. Concomitant infection which would preclude evaluation of the response to study
- •intervention.
- •7. Concomitant condition precluding evaluation of clinical response (such as acute
- •mastoiditis, facial palsy, bacterial meningitis, and brain tumor) that would
- •preclude evaluation of the response to study intervention.
- •8. Congenital disorders such as maxillofacial dysplasia.
- •9. Spontaneous perforation of the tympanic membrane and drainage for longer than
- •10. Tympanoplastic tube(s) in place, or has anatomic abnormalities associated with
- •recurrent AOM, prolonged middle ear effusion, including cleft palate or repair,
- •high-arched palate, or Downâ??s syndrome.
- •11. Severe cases of CABP including Hypoxemic, Septic, Ventilator-associated or
- •hospital-acquired pneumonia
- •12. Need corticosteroid for systemic (inhalational steroids as controller therapy in
- •asthma is allowed)
- •13. Infectious mononucleosis
- •14. Evidence of leukopenia and/or thrombocytopenia.
- •15. History of previous hypersensitivity reaction to penicillins, cephalosporins or
- •other Beta-lactam antibiotics.
- •16. History of AMC/CVA-associated cholestatic jaundice/hepatic dysfunction.
- •17. History of phenylketonuria or a known hypersensitivity to aspartame.
- •18. Received, within 48 hours of study entry, or is scheduled to receive during the
- •study period, any medication which may alter bowel function.
- •19. Currently receiving or has received more than one dose of systemic antibiotic
- •therapy within one week prior to the initiation of the study.
- •20. Receipt of an investigational compound (non-FDA and non-DCGI approved) or
- •device within the previous 30 days or five half-lives, whichever is longer,
- •preceding the first dose of study intervention or during the study.
- •21. Participants with symptoms suggestive of active COVID-19 infection (ie, fever,
- •cough, etc).
- •22. Participants with known COVID-19 positive contacts within the past 14 days.
研究者
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