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RCT of Efficacy of Amoxicillin Over Ampicillin on Severe Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03369093
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Burden: Pneumonia remains the leading infectious cause of death accounting 920,000 children under five around the world. This means a loss over 2,500 child lives every day, or over 100 every hour. Since 2000, the number of child deaths caused by pneumonia has decreased by 47 per cent. The tremendous progress made is due in part to the rapid roll-out of vaccines, better nutrition and improved care-seeking and treatment for symptoms. However, pneumonia hasn't declined as quickly as other diseases such as malaria (58%), HIV/AIDS (61%) and measles (85%).

Knowledge gap: The Lancet Series on Childhood Pneumonia and Diarrhea has reported that case management is one of the three most effective interventions to reduce pneumonia deaths in children. It is also noted that cost effectiveness of these interventions in national health system needs urgent assessment. It was suggested to find out means to reduce hospital stay without compromising the quality of care.

Relevance: The main purpose of our study is to compare the efficacy of two doses of parenteral Amoxicillin plus single dose Gentamicin compared to four doses of parenteral Ampicillin plus single dose Gentamicin. After 72 hours of treatment injectable Amoxicillin or injection Ampicillin will be switched to or replaced by oral Amoxicillin and will be discharged with an advice to attend to Ambulatory Care Unit (ACU) to receive once daily dose of injection Gentamicin for total 5 days. It is anticipated that this modified therapy will reduce hospitalization stay of children with severe pneumonia and would therefore be relevance in countries with resource poor setting. By reducing hospitalization period, this therapy has potentials to reduce hospital acquired infection.

Hypothesis (if any): Rate of treatment failure with two doses of injectable Amoxicillin plus single dose Gentamicin will be not more than that of four doses of injectable Ampicillin plus single dose Gentamicin in the management of children between 2 months to 59 months hospitalized for WHO classified severe pneumonia.

Condition or disease Intervention/treatment Phase
Treatment Failure Lethargy Altered Mental Status Convulsion, Non-Epileptic Hypoxia Feeding; Difficult, Newborn Drug: Amoxicillin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Two Doses of Parenteral Amoxicillin Plus Single Dose Gentamicin Compared to Four Doses of Parenteral Ampicillin Plus Single Dose Gentamicin in Managing Children Hospitalized With WHO Classified Severe Pneumonia: a RCT
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Active Comparator: Ampicillin arm
Ampicillin arm: Patients will receive four doses of parenteral Ampicillin and single dose of Gentamicin daily for 3-5 days
Drug: Amoxicillin
Twice daily doses of injectable amoxicillin
Other Name: no other intervention

Experimental: Amoxicillin arm
Amoxicillin arm: Patients will receive two doses of Amoxicillin and single dose of Gentamicin daily for 3-5 days
Drug: Amoxicillin
Twice daily doses of injectable amoxicillin
Other Name: no other intervention

Primary Outcome Measures :
  1. Treatment failure [ Time Frame: within 48 hours ]
    Persistence of danger signs of severe pneumonia such as hypoxia, feeding difficulty, abnormal mentation after 48 hours or new appearance of danger sign within 24 hours

Secondary Outcome Measures :
  1. Time of resolution or recovery from pneumonia period for pneumonia [ Time Frame: 48 hours ]
    Recovery from features of pneumonia in terms of respiratory distress, abnormal chest auscultation finding

  2. Total length of hospitalization [ Time Frame: 3-5 days ]
    Period of hospitalization

  3. Nosocomial infection [ Time Frame: 7 days ]
    any hospital acquired infection proven by laboratory facility

  4. Post discharge morbidity [ Time Frame: 30 days ]
    Follow up over phone to get information of any mild illness at home after discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

1. WHO classified severe pneumonia

Exclusion Criteria:

  1. Very sick children require mechanical ventilation
  2. Children with any congenital or structural defect

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03369093

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Contact: Lubaba Shahrin, Dr +8801754598328
Contact: MJ Chisti, PhD +8801749292703

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Dhaka Hospital, icddr,b Recruiting
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
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Principal Investigator: Lubaba Shahrin, MBBS, FCPS Dhaka Hospital

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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh Identifier: NCT03369093     History of Changes
Other Study ID Numbers: PR-17061
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
severe pneumonia
under five

Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Neurobehavioral Manifestations
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action