RCT of Efficacy of Amoxicillin Over Ampicillin on Severe Pneumonia

NCT03369093 | Completed DMC

• 1 other identifier: PR-17061
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

Burden: Pneumonia remains the leading infectious cause of death accounting for 920,000 children under five around the world. This means a loss of 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 percent. 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 the cost-effectiveness of these interventions in the 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 the 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 a once-daily dose of injection Gentamicin for a total of 5 days. It is anticipated that this modified therapy will reduce the hospitalization stay of children with severe pneumonia and would therefore be relevant in countries with the resource-poor settings. By reducing the hospitalization period, this therapy has the 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 no 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.

Conditions

Treatment Failure; Lethargy; Altered Mental Status; Convulsion, Non-Epileptic; Hypoxia; Feeding; Difficult, Newborn

Keywords

RCT; severe pneumonia; amoxicillin; under five

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  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

  within 48 hours

Secondary Outcomes (4)

• Time of resolution or recovery from pneumonia period for pneumonia

  48 hours

• Total length of hospitalization

  3-5 days

• Nosocomial infection

  7 days

• Post discharge morbidity

  30 days

Study Arms (2)

Ampicillin arm

ACTIVE COMPARATOR

Ampicillin arm: Patients will receive four doses of parenteral Ampicillin and single dose of Gentamicin daily for 3-5 days

Drug: Amoxicillin

Amoxicillin arm

EXPERIMENTAL

Amoxicillin arm: Patients will receive two doses of Amoxicillin and single dose of Gentamicin daily for 3-5 days

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

Twice daily doses of injectable amoxicillin

Also known as: no other intervention

Amoxicillin arm; Ampicillin arm

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. WHO classified severe pneumonia

You may not qualify if:

• Very sick children require mechanical ventilation
• Children with any congenital or structural defect

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Dhaka Hospital, icddr,b

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Shahrin L, Chisti MJ, Shahid ASMSB, Rahman ASMMH, Islam MZ, Afroze F, Huq S, Ahmed T. Injectable Amoxicillin Versus Injectable Ampicillin Plus Gentamicin in the Treatment of Severe Pneumonia in Children Aged 2 to 59 Months: Protocol for an Open-Label Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 2;9(11):e17735. doi: 10.2196/17735.

  PMID: 33136058 BACKGROUND

MeSH Terms

Conditions

Lethargy; Seizures; Hypoxia; Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lubaba Shahrin, MBBS, FCPS

  Dhaka Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This was an unblinded intervention trial. Blinding could not be justified by the ethical review committee as the schedule of administration of the drugs was different and drug dispensing-related side effects were investigators' other concern.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators have completed the enrollment of 308 participants by the study endline. All the Serious adverse events have been reported appropriately to the Ethical Review Committee and the Data Safety and Monitoring Board (DSMB)

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: December 11, 2017
• Study Start: January 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)