PneumoniaNCT00227331
Equivalency Of Oral Amoxicillin Vs Injectable Penicillin In Children With Severe Pneumonia
A study testing Oral amoxicillin in people with Pneumonia, run by Boston Medical Center.
Trial summary
This is a clinical trial to determine if oral amoxicillin is equivalent in efficacy to injectable penicillin (the standard treatment) in the treatment of WHO-defined severe pneumonia in children between the ages of 2 and 59 months. Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- Oral amoxicillin
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1998to Jan 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 59 months
- All sexes
- Child
Who may be able to join
- Children aged three to 59 months admitted with severe pneumonia. Severe pneumonia is defined as lower chest indrawing in children with cough and/or difficult breathing, who are able to drink and do not have central cyanosis, regardless of the respiratory rate. Known HIV infected patients in clinical category N or A (CDC) will be included.
Who cannot join
- Presence of any danger sign during current illness (convulsions, abnormally sleepy or difficult to awake, stridor in a calm child).
- Severe malnutrition defined as weight for age equal or less than -3 SD or kwashiorkor).
- Hospitalization in the last two weeks. This will exclude cases with possible nosocomial pneumonia that could require second line antibiotics.
- Known prior episodes of asthma. These patients may have respiratory distress without infection and most often do not need antibiotics. Children having had 3 or more episodes of wheezing in the past will also be excluded. Wheezing that improves after receiving bronchodilator therapy, as explained in the footnote . These children may have asthma.
- Measles in the last month. These patients may have immune suppression.
- Previous history of HIV infection in clinical category B or C (CDC). These patients have immune suppression and infections that may require other diagnostic or treatment measures (see annex 1, page 39).
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- Known or clinically recognizable chronic conditions (congenital cardiac or respiratory anomalies, chronic lung disease including bronchopulmonary dysplasia, neurological impairment that affects respiratory function, renal diseases, malignant or hematological diseases).
- Other diseases requiring antibiotic therapy on presenting, such as meningitis, evident tuberculosis, dysentery, osteomyelitis, septic arthritis, etc. Use of other antibiotics needed for treatment.
- Children Lower Chest Indrawing due to non-infective cause such cardiac failure, active rickets, or severe anemia, or with signs of severe dehydration according to WHO criteria (see annex 2, page 42).
- Children with SaO2 <80% in room air at sea level, or SaO2 < 75% in Bogota and Mexico (for measurement of oxygen saturation see Study Manual).
- Known prior anaphylactic reaction to penicillin or amoxycillin.
- Known antibiotic therapy for 48 hours or more prior to admission. Clinically, these children would be considered for a change of treatment to second line antibiotics on admission. Evidence of antibiotic use include any of the following: a) parental report that an antibiotics has been given; b) parent can provide evidence for prescription for antibiotics or c) has the container with antibiotic or d) recognizes medication when shown appropriate containers for locally available antibiotics. Children that have received antibiotics for less than 48 hours prior to admission will be accepted in the trial.
- Inability to receive oral medications (three or more episodes of vomiting per hour). These children should not be given oral antibiotics.
- Previous inclusion in the trial or children already included in another trial.
- Living outside the catchment area of the hospital. These patients may be difficult to follow after discharge.
- Parental or caretaker refusal to participate in the trial.
About this study
Official title: A Randomized Multicentre Equivalency Study Of Oral Amoxicillin Versus Injectable Penicillin In Children Aged 3 To 59 Months With Severe Pneumonia
This is a clinical trial to determine if oral amoxicillin is equivalent in efficacy to injectable penicillin (the standard treatment) in the treatment of WHO-defined severe pneumonia in children between the ages of 2 and 59 months.
Read the detailed description
BACKGROUND Injectable penicillin is recommended treatment for WHO-defined severe pneumonia (lower chest indrawing [LCI]). Oral amoxicillin, if found equally effective, could reduce referral, hospitalization, and treatment costs. We aimed to determine whether oral amoxicillin and parenteral penicillin were equivalent in the treatment of severe pneumonia in children aged 3-59 months.
METHODS This multicentre randomized, open label equivalency study was conducted at tertiary care centres in 8 countries. Children aged 3-59 months with severe pneumonia were hospitalized for 48 hours and, if improved, discharged with a 5-day course of oral amoxicillin. Follow-up evaluation occurred at 5 and 14 days after enrolment. The primary outcome was treatment failure (persistence of LCI or new danger signs) at 48 hours. Analyses were by intention to treat and per protocol.
RESULTS 1702 children were randomized to receive either oral amoxicillin (857) or parenteral penicillin (845) for 48 hours. Treatment failure was 19% in each group (risk difference -0.4; 95% CI -4.2 to 3.3) at 48 hours, 22% (cumulative) in each group at 5 days, and 25% in each group at 14 days. Relapse at day 5 and 14 occurred in 45/1375 (3.4%) and 65/1330 (4.8%) of the children, respectively. Infancy (OR 2.72, 95% CI 1.95-3.79), very fast breathing (1.94, 1.42-2.65) and hypoxia (1.95, 1.34-2.82) at baseline predicted treatment failure by multivariate analysis.
CONCLUSIONS Injectable penicillin and oral amoxicillin are equivalent in the treatment of severe pneumonia in developing world areas in a controlled environment. Additional research is needed in a public health setting in rural and urban areas before these finding can be recommended for widespread implementation. Potential benefits of oral therapy for pneumonia include a decrease in the 1) the risk of needle-borne infections; 2) need for referral or hospitalization; 3) administration costs and 4) costs to the family. (word count 294).
- Conditions
- Pneumonia
- Being tested
- Oral amoxicillin
- Keywords
- Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral amoxicillinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was treatment failure at 48 hours.
Secondary outcomes (1)
Secondary outcomes were treatment failure at five days and 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJan 1998
- Study completionJan 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Investigators
- Shamim Qazi, MD, Study chair, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227331
- Sponsor's protocol ID
- HRN-A-00-96-90010-00-1
- Status last verified
- Sep 2005
- First submitted
- 26 Sep 2005
- Last updated
- 3 May 2006
- Results posted
- No
Publications
Jeena P, Thea DM, MacLeod WB, Chisaka N, Fox MP, Coovadia HM, Qazi S; Amoxicillin Penicillin Pneumonia International Study (APPIS Group). Failure of standard antimicrobial therapy in children aged 3-59 months with mild or asymptomatic HIV infection and severe pneumonia. Bull World Health Organ. 2006 Apr;84(4):269-75. doi: 10.2471/blt.04.015222. Epub 2006 Apr 13.
PubMed 16628299
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicentre Equivalency Study Of Oral Amoxicillin Versus Injectable Penicillin In Children Aged 3 To 59 Months With Severe Pneumonia
- ClinicalTrials.gov ID
- NCT00227331
- Acronym / sponsor ID
- HRN-A-00-96-90010-00-1
- Conditions
- Pneumonia
- Keywords
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Jan 1998
- Study completion
- Jan 2000
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial to determine if oral amoxicillin is equivalent in efficacy to injectable penicillin (the standard treatment) in the treatment of WHO-defined severe pneumonia in children between the ages of 2 and 59 months.
Detailed description
BACKGROUND Injectable penicillin is recommended treatment for WHO-defined severe pneumonia (lower chest indrawing [LCI]). Oral amoxicillin, if found equally effective, could reduce referral, hospitalization, and treatment costs. We aimed to determine whether oral amoxicillin and parenteral penicillin were equivalent in the treatment of severe pneumonia in children aged 3-59 months.
METHODS This multicentre randomized, open label equivalency study was conducted at tertiary care centres in 8 countries. Children aged 3-59 months with severe pneumonia were hospitalized for 48 hours and, if improved, discharged with a 5-day course of oral amoxicillin. Follow-up evaluation occurred at 5 and 14 days after enrolment. The primary outcome was treatment failure (persistence of LCI or new danger signs) at 48 hours. Analyses were by intention to treat and per protocol.
RESULTS 1702 children were randomized to receive either oral amoxicillin (857) or parenteral penicillin (845) for 48 hours. Treatment failure was 19% in each group (risk difference -0.4; 95% CI -4.2 to 3.3) at 48 hours, 22% (cumulative) in each group at 5 days, and 25% in each group at 14 days. Relapse at day 5 and 14 occurred in 45/1375 (3.4%) and 65/1330 (4.8%) of the children, respectively. Infancy (OR 2.72, 95% CI 1.95-3.79), very fast breathing (1.94, 1.42-2.65) and hypoxia (1.95, 1.34-2.82) at baseline predicted treatment failure by multivariate analysis.
CONCLUSIONS Injectable penicillin and oral amoxicillin are equivalent in the treatment of severe pneumonia in developing world areas in a controlled environment. Additional research is needed in a public health setting in rural and urban areas before these finding can be recommended for widespread implementation. Potential benefits of oral therapy for pneumonia include a decrease in the 1) the risk of needle-borne infections; 2) need for referral or hospitalization; 3) administration costs and 4) costs to the family. (word count 294).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged three to 59 months admitted with severe pneumonia. Severe pneumonia is defined as lower chest indrawing in children with cough and/or difficult breathing, who are able to drink and do not have central cyanosis, regardless of the respiratory rate. Known HIV infected patients in clinical category N or A (CDC) will be included.
Key exclusion criteria (16 listed)
- Presence of any danger sign during current illness (convulsions, abnormally sleepy or difficult to awake, stridor in a calm child).
- Severe malnutrition defined as weight for age equal or less than -3 SD or kwashiorkor).
- Hospitalization in the last two weeks. This will exclude cases with possible nosocomial pneumonia that could require second line antibiotics.
- Known prior episodes of asthma. These patients may have respiratory distress without infection and most often do not need antibiotics. Children having had 3 or more episodes of wheezing in the past will also be excluded. Wheezing that improves after receiving bronchodilator therapy, as explained in the footnote . These children may have asthma.
- Measles in the last month. These patients may have immune suppression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral amoxicillin | Drug | – |
Primary outcome
The primary outcome was treatment failure at 48 hours.
1 secondary outcome
Secondary outcomes were treatment failure at five days and 14 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2006.
- Results publication: PubMed 16628299Jeena P, Thea DM, MacLeod WB, Chisaka N, Fox MP, Coovadia HM, Qazi S; Amoxicillin Penicillin Pneumonia International Study (APPIS Group). Failure of standard antimicrobial therapy in children aged 3-59 months with mild or asymptomatic HIV infection and severe pneumonia. Bull World Health Organ. 2006 Apr;84(4):269-75. doi: 10.2471/blt.04.015222. Epub 2006 Apr 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamim Qazi, MD study chair
World Health Organization
Questions about this trial
What is this clinical trial studying?
A study testing Oral amoxicillin in people with Pneumonia, run by Boston Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was treatment failure at 48 hours.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00227331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2006.