Trial on the Ideal Duration of Oral Antibiotics in Children With Pneumonia

NCT02258763 | Completed Phase 4

• 1 other identifier: RP026-14HTM
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

To determine, in children hospitalized with pneumonia, if an extended duration of oral antibiotics (10 days) will be superior to a shorter duration (3 days) of antibiotics in improving clinical outcomes. Secondary Aims:

1. 1.Describe the prevalence of respiratory viruses and bacteria at presentation.
2. 2.Investigate the depression, anxiety and stress scores (DASS21) and quality of life scored (QOL) by parents of the children during admission, pre-discharge and post discharge and at follow-ups.

Conditions

Pneumonia

Keywords

Pneumonia; Child; Outcome; Antibiotics; Etiology

Outcome Measures

Primary Outcomes (1)

• Clinical cure

  Complete resolution of symptoms. No treatment failure or exit failure i.e. need for antibiotics or readmission into hospital for a respiratory condition

  30 days

Secondary Outcomes (10)

• Quality of life of child and parent

  on admission, at discharge, at follow-ups( 4 weeks, 6 months and 1 year)

• Impact of pneumonia on the parent

  on admission, at discharge, at follow-ups(average 1 week, 4 weeks, 6 months and 1 year)

• Severity of pneumonia

  during the admission which expected duration will be 5 days, daily twice a day to do the questionnaires

• Adverse effects

  at 4 weeks follow-up

• Time to next hospitalisation or visit to healthcare unit

  during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 year

Other Outcomes (1)

• Cost effective analysis of long vs short course of antibiotics for pneumonia

  at the 4 weeks appointment

Study Arms (2)

Amoxicillin-Potassium Clavulanate

EXPERIMENTAL

Patient will be on amoxicillin-clavulanate 22.5mg/kg/dose bd for 10 days

Drug: Amoxicillin-Potassium Clavulanate Combination

Placebo

ACTIVE COMPARATOR

Patient will be on amoxicillin-clavulanate 22.5mg/kg/bd for 3 days followed by another 7 days of placebo medication given at the same dose and frequency

Drug: Amoxicillin-Potassium Clavulanate Combination; Drug: Placebo

Interventions

Amoxicillin-Potassium Clavulanate Combination DRUG

Oral antibiotic for 10 days

Also known as: Augmentin, Clomovid, Co-amoxiclav

Amoxicillin-Potassium Clavulanate; Placebo

Placebo DRUG

Placebo made to look like the study drug-main ingredient sugar syrup made by the pharmacy department in the hospital In the placebo arm, patient will be given 3 days of antibiotic followed by 7 days of placebo

Also known as: Placebo arm

Placebo

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children admitted with severe pneumonia as defined by the presence of all the following as defined as below:
• months to 59 months old
• History of cough and/or shortness of breath
• Unwell for \<= 7 days -Increased respiratory rate ( ≥ 50/min if ≤12 months old, ≥ 40/min) or retractions,-
• Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation\< 92% on air, poor feeding or lethargy
• Documented fever (axillary /central temp ≥ 38/38.5°C) within 24 hrs of admission
• Abnormal CXR with presence of alveolar infiltrates
• Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms

You may not qualify if:

• Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie \>7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia- (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia

Sponsors & Collaborators

• University of Malaya: lead
• Menzies School of Health Research: collaborator

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Lembah Pantai, 59100, Malaysia

Location

Related Publications (11)

• Rudan I, Boschi-Pinto C, Biloglav Z, Mulholland K, Campbell H. Epidemiology and etiology of childhood pneumonia. Bull World Health Organ. 2008 May;86(5):408-16. doi: 10.2471/blt.07.048769.

  PMID: 18545744 RESULT

• Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, O'Brien KL, Campbell H, Black RE. Global burden of childhood pneumonia and diarrhoea. Lancet. 2013 Apr 20;381(9875):1405-1416. doi: 10.1016/S0140-6736(13)60222-6. Epub 2013 Apr 12.

  PMID: 23582727 RESULT

• Chang AB, Byrnes CA, Everard ML. Diagnosing and preventing chronic suppurative lung disease (CSLD) and bronchiectasis. Paediatr Respir Rev. 2011 Jun;12(2):97-103. doi: 10.1016/j.prrv.2010.10.008. Epub 2010 Dec 4.

  PMID: 21458737 RESULT

• Trenholme AA, Byrnes CA, McBride C, Lennon DR, Chan-Mow F, Vogel AM, Stewart JM, Percival T. Respiratory health outcomes 1 year after admission with severe lower respiratory tract infection. Pediatr Pulmonol. 2013 Aug;48(8):772-9. doi: 10.1002/ppul.22661. Epub 2012 Sep 19.

  PMID: 22997178 RESULT

• Gilani Z, Kwong YD, Levine OS, Deloria-Knoll M, Scott JA, O'Brien KL, Feikin DR. A literature review and survey of childhood pneumonia etiology studies: 2000-2010. Clin Infect Dis. 2012 Apr;54 Suppl 2(Suppl 2):S102-8. doi: 10.1093/cid/cir1053.

  PMID: 22403223 RESULT

• Yasin RM, Zin NM, Hussin A, Nawi SH, Hanapiah SM, Wahab ZA, Raj G, Shafie N, Peng NP, Chu KK, Aziz MN, Maning N, Mohamad JS, Benjamin A, Salleh MA, Zahari SS, Francis A, Ahmad N, Karunakaran R. Current trend of pneumococcal serotypes distribution and antibiotic susceptibility pattern in Malaysian hospitals. Vaccine. 2011 Aug 5;29(34):5688-93. doi: 10.1016/j.vaccine.2011.06.004. Epub 2011 Jun 30.

  PMID: 21723357 RESULT

• Chan PW, Goh AY, Chua KB, Kharullah NS, Hooi PS. Viral aetiology of lower respiratory tract infection in young Malaysian children. J Paediatr Child Health. 1999 Jun;35(3):287-90. doi: 10.1046/j.1440-1754.1999.00359.x.

  PMID: 10404452 RESULT

• Kulpeng W, Sornsrivichai V, Chongsuvivatwong V, Rattanavipapong W, Leelahavarong P, Cairns J, Lubell Y, Teerawattananon Y. Variation of health-related quality of life assessed by caregivers and patients affected by severe childhood infections. BMC Pediatr. 2013 Aug 13;13:122. doi: 10.1186/1471-2431-13-122.

  PMID: 23941314 RESULT

• Shoham Y, Dagan R, Givon-Lavi N, Liss Z, Shagan T, Zamir O, Greenberg D. Community-acquired pneumonia in children: quantifying the burden on patients and their families including decrease in quality of life. Pediatrics. 2005 May;115(5):1213-9. doi: 10.1542/peds.2004-1285.

  PMID: 15867027 RESULT

• Edmond K, Scott S, Korczak V, Ward C, Sanderson C, Theodoratou E, Clark A, Griffiths U, Rudan I, Campbell H. Long term sequelae from childhood pneumonia; systematic review and meta-analysis. PLoS One. 2012;7(2):e31239. doi: 10.1371/journal.pone.0031239. Epub 2012 Feb 22.

  PMID: 22384005 RESULT

• Jimenez Ortega AI, Lopez-Neyra A, Sanz Santiago V, Alvarez-Coca J, Villa Asensi JR. [Pulmonary function in children following community-acquired pneumonia contracted at pre-school age]. An Pediatr (Barc). 2011 Nov;75(5):314-9. doi: 10.1016/j.anpedi.2011.05.002. Epub 2011 Jul 31. Spanish.

  PMID: 21684825 RESULT

MeSH Terms

Conditions

Pneumonia

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and Associate Professor

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 7, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: October 1, 2018
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

MY (1)