CLINICAL TRIALS PROFILE FOR PENICILLIN G PROCAINE
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All Clinical Trials for PENICILLIN G PROCAINE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00189384 ↗ | Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants | Unknown status | Aga Khan University | Phase 3 | 2003-11-01 | Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth. Current World Health Organization recommendations for the management of infants younger than 2 months of age who have serious bacterial infections involve hospitalization and parenteral therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin combined with an aminoglycoside.However, in many settings throughout the developing world, this is not currently possible, nor is this standard of care likely to be feasible in the near future. Several studies have reported that for a variety of sociocultural reasons many families are unable or unwilling to access hospital-based care and their sick young infants do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies, or none at all. In our community field sites, approximately 70% of families refuse hospital referral for a sick newborn, despite provision of transport. Thus, there is an urgent need to define the role of community/first-level facility-based care versus hospitalization for the management of young infants with serious bacterial infections, and the potential for community-based parenteral antibiotics as an alternative strategy in resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated significant reductions in neonatal mortality from infections in an underdeveloped rural district in Maharashtra, India by a field-based case management approach which used oral cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with sepsis. This study is an equivalence randomized controlled trial (RCT) comparing once daily IM ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or sepsis with or without local infections such as skin or umbilical infections) whose families refused referral to a hospital. After supplementary informed consent, patients meeting specific inclusion and exclusion criteria are randomly allocated to one of the three regimens being tested. The study hypothesis is that all 3 regimens will perform equally well in the treatment of sepsis in a first-level facility setting. |
| NCT00844337 ↗ | Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh | Completed | Dhaka Shishu Hospital | N/A | 2009-03-01 | The primary aim is to establish the non-inferiority of several simplified, home-based antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse hospitalization. Three alternative regimens will be compared with a standard (reference) regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily for five days. Hypothesis The proportion who fails treatment will be 10 percent in the reference group and the alternative treatment groups. An alternative therapy will be considered non-inferior to the standard therapy if the failure rate in the alternative therapy exceeds the failure rate in the injectable therapy by less than 5 absolute percentage points. Secondary Objectives: - To identify baseline clinical predictors of treatment failure in severe infections in young infants. - To determine the proportion of relapse (young infants who were considered cured by day 7 but developed any of the signs of suspected severe infection by day 14). |
| NCT00844337 ↗ | Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh | Completed | Johns Hopkins Bloomberg School of Public Health | N/A | 2009-03-01 | The primary aim is to establish the non-inferiority of several simplified, home-based antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse hospitalization. Three alternative regimens will be compared with a standard (reference) regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily for five days. Hypothesis The proportion who fails treatment will be 10 percent in the reference group and the alternative treatment groups. An alternative therapy will be considered non-inferior to the standard therapy if the failure rate in the alternative therapy exceeds the failure rate in the injectable therapy by less than 5 absolute percentage points. Secondary Objectives: - To identify baseline clinical predictors of treatment failure in severe infections in young infants. - To determine the proportion of relapse (young infants who were considered cured by day 7 but developed any of the signs of suspected severe infection by day 14). |
| NCT01027429 ↗ | Simplified Antibiotic Therapy for Sepsis in Young Infants | Completed | Emory University | Phase 3 | 2009-12-01 | This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families. |
| NCT01027429 ↗ | Simplified Antibiotic Therapy for Sepsis in Young Infants | Completed | London School of Hygiene and Tropical Medicine | Phase 3 | 2009-12-01 | This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families. |
| NCT01027429 ↗ | Simplified Antibiotic Therapy for Sepsis in Young Infants | Completed | Save the Children | Phase 3 | 2009-12-01 | This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families. |
| NCT01027429 ↗ | Simplified Antibiotic Therapy for Sepsis in Young Infants | Completed | World Health Organization | Phase 3 | 2009-12-01 | This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families. |
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