scholarly journals Safety and efficacy of different drug forms of amoxicillin / clavulanic acid in treatment of lower respiratory tract infections in adults: an open prospective randomized trial

2008 ◽  
pp. 73-80
Author(s):  
I. A. Guchev ◽  
R. S. Kozlov

Amoxicillin/clavulanic acid (ACA) is one of the drugs of choice for treatment of lower respiratory tract infections (LRTI) in adults. One of the serious disadvantages of ACA is relatively high rate of gastrointestinal adverse events (AE). A new form of ACA, which is dispersable tablets Solutab, could potentially reduce the rate of AE because of more rapid and predictable absorption of clavulanic acid from intestine and improve clinical outcomes due to higher adherence to treatment. This trial was aimed to compare AE rate and clinical efficacy of the new dispersable ACA form Solutab with those of traditional ACA tabs in adult patients with non-severe LRTI. The treatment regimen comprised 500/125 mg t.i.d. during 5 to12 days. This was an open, prospective randomized trial performed at 4 clinical centres. Adults with clinically and radiologically detected non-severe community-acquired pneumonia or I or II types COPD exacerbations with purulent sputum received dispersable ACA tablets (the 1st group) or traditional coated tabs of ACA (the 2nd group) in a random proportion of 1 : 1. Clinical efficacy was evaluated with clinical signs, physical symptoms, additional laboratory and instrumental testing. The safety was assessed based on the patient's complaints and results of physical and laboratory examination in visits 2 (Day 3 or 4), 3 (Day 5 to 12), and 4 (Day 30 to 40 after taking the first dose of the drug). The trial involved 200 patients, the mean age, 32.7 ± 18.7 and 33.3 ± 18.6 yrs in the 1st and the 2nd groups, respectively. The groups were similar for history, severity, and clinical course of the disease. Clinical efficacy was 96.9 % in both groups in visit 3, 95.9 % and 96.9 % in the 1st and the 2nd group, respectively, in visit 4. The mean duration of antibacterial therapy was 7.1 ± 1.5 days in the 1st group and 7.2 ± 1.4 days in the 2nd group. AE were reported in 15 % and 31 % of the patients, respectively (p = 0.01). Gastrointestinal AE predominated in both the groups but the rate of diarrhea was lower in patients receiving dispersable ACA: 6 % vs. 17 % in the 2nd group (p = 0.027). Therefore, the new dispersable drug form of ACA has better safety profile in adult patients with non-severe LRTI compared to traditional ACA that was demonstrated by reduction in the AE, mainly diarrhea, rate. Both drug forms showed equally high clinical efficacy.

2008 ◽  
Vol 36 (6) ◽  
pp. 1293-1304 ◽  
Author(s):  
A Pareek ◽  
S Pednekar ◽  
HB Prasad ◽  
S Salagre ◽  
N Chandurkar

This randomized, multicentre, comparative study evaluated the efficacy and safety of treatment with cefuroxime–sulbactam compared with amoxicillin–clavulanic acid (co-amoxiclav) in patients with lower respiratory tract infections (LRTIs). The study enrolled 75 adult inpatients with moderate to severe LRTIs. Patients were treated intravenously for 7 − 10 days. The treatment groups were comparable at baseline with respect to demographic and disease characteristics. Efficacy was evaluated in 72 patients. The clinical success rate was statistically superior in patients treated with cefuroxime–sulbactam (100%) compared with patients treated with amoxicillin–clavulanic acid (88%). The bacteriological success rate was 95% and 100% for cefuroxime–sulbactam and amoxicillin–clavulanic acid, respectively, with no significant difference between treatments. Both treatments were safe and well tolerated. One patient in the cefuroxime–sulbactam group reported convulsions, which the investigator considered were probably not related to the study medication. Cefuroxime–sulbactam can be an effective alternative empirical treatment for LRTIs.


2021 ◽  
Vol 17 ◽  
Author(s):  
Alfian Nur Rosyid ◽  
Pepy Dwi Endraswari ◽  
Tutik Kusmiati ◽  
Arina Dery Puspitasari ◽  
Abdul Khairul Rizki Purba ◽  
...  

Background: Empirical antibiotics among outpatients with Lower Respiratory Tract Infections (LRTIs) are scarcely allocated in Indonesia. The study aims to evaluate the pathogens causing LRTIs, drug sensitivity test and the minimum inhibitory concentrations of 90% (MIC90) of Cefditoren, Azithromycin, Amoxicillin-Clavulanic Acid, and Cefixime Methods: The study was performed in adult outpatients with LRTI that can be expectorated. Patients with diabetes mellitus, HIV, lung tuberculosis, renal or hepatic failure, and hemoptysis were excluded. We performed bacterial culture, antibiotic sensitivity, and MIC measurement of four antibiotics. Results: There were 126 patients with LRTIs, and 61 patients were eligible for the study. We identified 69 bacteria. We found Klebsiella pneumonia (n=16; 26.23%), Staphylococcus aureus (n=11; 18%), Pseudomonas aeruginosa (n=8; 13.11%), Acinetobacter baumanii complex (n= 4; 6.55%), Streptococcus pneumonia (n=3; 4.9%) and others bacteria as causa of LRTI. Testing MIC90 of Cefditoren and three empiric antibiotics on LRTI found that Cefditoren has a lower MIC of 90 for K. pneumonia (0.97(2.04) µg.mL-1) and S. pneumonia (0.06(0.00)µg.mL-1) than other antibiotics, but almost the same as Cefixime ((0.05(0.16)µg.mL-1) and (0.38(0.17)µg.mL-1). MIC90 Cefditoren for S.aureus (3.18(3.54)µg.mL-1) and P.aeruginosa (9.2(3.53)µg.mL-1) is lower than Cefixime but higher than Azithromycin and Amoxicillin-Clavulanic acid. Reference data MIC90 of Cefditoren for LRTI bacteria is lower than the other three oral empirical antibiotics. Conclusions: In vitro studies of an outpatient LRTI in Surabaya found gram-negative bacteria dominant. Cefditoren can inhibit K.pneumonia and S.pneumonia has lower MIC90 compared to other antibiotics. Cefditoren can inhibit gram-negative and positive bacteria causing LRTI.


1993 ◽  
Vol 21 (2) ◽  
pp. 98-101 ◽  
Author(s):  
G Tatsis ◽  
M Veslemes ◽  
C Hadjistavrou ◽  
A Votsiou ◽  
J Jordanoglou

Patients with lower respiratory tract infections [pneumonia ( n = 16), bronchiectasis ( n = 5) and acute exacerbations of chronic bronchitis ( n = 44)] were treated daily with amoxycillin/clavulanic acid given either 1.2 g intravenously three times daily or 625 mg orally three times daily for 7–15 days. Symptoms, signs and sputum volume and colour were monitored daily. Chest X-ray, sputum culture and Gram-stain examinations were also carried out on days 1 and 5, and immediately after the end of the treatment. There was a clinical improvement, as indicated by the incidence of cough, dyspnoea and rales, and by sputum volume and colour in 90.8% of the patients. Microbiological improvement, as indicated by the complete elimination of sputum pathogens and pus cells, was achieved in the same proportion of patients (90.8%). In one patient, an adverse side-effect, diffuse exanthema, was noted. Amoxycillin/clavulanic acid possesses a high clinical and microbiological efficacy for lower respiratory tract infections.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S747-S747
Author(s):  
Don Bambino Geno Tai ◽  
Robert Goldstein

Abstract Background Procalcitonin (PCT) is a promising and well-studied marker in differentiating viral from bacterial lower respiratory tract infections (LRTI). Antibiotics are not recommended when PCT is normal (< 0.25 μg/L). Despite this, it has not been the standard of care due to safety concerns of relying on PCT to withhold antibiotics. Methods We retrospectively reviewed all non-critical LRTI patients with normal PCT admitted in our institution from October 2018 to March 2019. They were divided into adherent group in whom antibiotics were discontinued within 24 hours and non-adherent group in whom antibiotics were continued. Cases of Legionella, Mycoplasma, and other infectious syndromes necessitating antibiotics were excluded. Complexity of cases was measured based on Centers for Medicare and Medicaid Services (CMS) case-mix index (CMI). Outcomes compared were the length of stay (LOS), in-hospital mortality, and 30-day all-cause readmissions. Results A total of 78 patients were included in the analysis, 52% (n = 41) were in adherent group and 48% (n = 37) in the non-adherent group. The mean age was 74, and majority were females (59%, n = 46). The were no significant differences between the two groups in terms of age, gender, CMI, underlying COPD/asthma, CHF (see Table 1). The adherent group had statistically shorter LOS compared with the non-adherent group after adjusting for CMI. There was no significant difference in In-hospital mortality and readmissions (see Table 2). Furthermore, the adherent group’s LOS was statistically similar to CMS average LOS (5.08 vs. 3.8, P = 0.08); compared with the non-adherent group which had statistically longer LOS compared with CMS average LOS (8.3 vs. 4.6, p Conclusion PCT is a safe tool in deciding when to withhold antibiotics on LRTI patients. It shortens LOS with no difference in mortality or readmission. Disclosures All authors: No reported disclosures.


Sign in / Sign up

Export Citation Format

Share Document