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At least 19 recordsLinked to original sources
PubMed1999

Randomised trial of pivampicillin plus pivmecillinam vs. pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae.

A prospective, randomised, single-blind comparative trial was carried out to determine whether double beta-lactam treatment with pivampicillin plus pivmecillinam is more effective than pivampicillin alone in the treatment of recurrent and chronic lung infections with Haemophilus influenzae in patients with chronic obstructive pulmonary disease (COPD) or cystic fibrosis (CF). Fifty-six children and young adults with COPD or CF were randomised to the clinical study. The patients were allocated at random to receive perorally either pivmecillinam, 40 mg/kg/day, combined with pivampicillin, 50 mg/kg/day, or pivampicillin 50 mg/kg/day alone for 14 days. A cross-over pharmacokinetic study using the same drugs was carried out in 10 CF patients to determine the antibiotic concentrations in serum and sputum after a single dose of each drug. The clinical study showed no significant differences in clinical scoring, lung function tests or adverse events after treatment with pivampicillin plus pivmecillinam or pivampicillin alone. Follow-up microbiological evaluation 2 and 6 weeks after the end of treatment showed that the offending pathogen was eradicated in 68% of the patients treated with pivampicillin plus pivmecillinam and in 67% of the patients treated with pivampicillin alone. Reinfection with another biotype was more common in the combination group (50% vs. 21%) than in the pivampicillin group. In the pharmacokinetic study the median peak serum concentration occurred two hours after intake of tablets. The efficacy of double beta lactam treatment in lung infections with H. influenzae appears to be equivalent to that of ampicillin on clinical lung symptoms, lung function tests, adverse effects and bacteriology.

Adolescent↗
PubMed1983

Double-blind comparison of pivmecillinam plus pivampicillin ('Miraxid') with pivampicillin alone in chronic bronchitis: a Danish multi-centre study.

A double-blind, multi-centre trial was carried out in 62 patients with purulent exacerbations of chronic bronchitis to compare the efficacy and tolerance of pivmecillinam plus pivampicillin with that of pivampicillin given alone. Patients were allocated at random to receive treatment with either 100 mg pivmecillinam plus 125 mg pivampicillin or 250 mg pivampicillin 3-times daily for 7 to 14 days. A satisfactory clinical response was observed in 28 (88%) out of the 32 patients given pivmecillinam/pivampicillin. Twenty-two (73%) out of the 30 subjects taking pivampicillin alone responded to therapy. Combination therapy appeared to be more effective in rendering purulent sputum mucoid. After treatment was completed, fewer pathogens including pneumococci, Haemophilus influenzae and Enterobacteriaceae were present in the sputum of patients given the combination (4 out of 14 cases) when compared to subjects who took pivampicillin alone (10 out of 15 cases). Both treatments were well tolerated. One patient taking pivmecillinam/pivampicillin and 5 subjects given pivampicillin reported mild gastro-intestinal discomfort.

Adult↗
PubMed1986

The combination of pivampicillin and pivmecillinam versus pivampicillin alone in the treatment of acute pyelonephritis.

96 patients with clinical symptoms of acute pyelonephritis were randomized to 2 weeks treatment with either a fixed combination of pivampicillin and pivmecillinam or to pivampicillin alone. If needed, treatment was first started with the respective parenteral equivalents of the drugs. Acute pyelonephritis was bacteriologically verified in 57 patients, in whom Escherichia coli was isolated in 80% of the cases, Klebsiella in 7% and Proteus mirabilis in 5%. 22 of the 39 patients excluded did not have significant bacteriuria (less than 10(8) c.f.u./l). Combination treatment was superior to pivampicillin/ampicillin alone, in terms of clinical effect, with successful treatment being noted in 93% in the combination group and in 53% in the ampicillin group (p = 0.002). The combination was also more effective bacteriologically and it did not select resistant strains in the urinary tract. Ampicillin treatment alone, was, however, associated with a significant increase in urinary strains resistant to ampicillin and to mecillinam. Unsuccessful responders had a significantly higher mean age (p less than 0.01) than successful responders. No serious side-effects were noted.

Acute Disease↗
PubMed1996

Bioavailability of pivampicillin and ampicillin trihydrate administered as an oral paste in horses.

Pivampicillin was administered as an oral paste to five healthy adult horses, and an oral paste with ampicillin trihydrate was administered to three horses. Pivampicillin was administered to both starved and fed horses, ampicillin trihydrate was administered to fed horses only. The dose of pivampicillin was 19.9 mg/kg, and the dose of ampicillin trihydrate was 17 mg/kg. Both doses are equivalent on a molecular basis to 15 mg/kg ampicillin. Ampicillin concentrations in plasma were determined up to 24 hours after administration. After administration of pivampicillin to starved and fed horses the mean areas under the plasma concentration-time curve (AUCs) were 23.0 and 19.3 micrograms.h.ml-1, respectively. After administration of ampicillin trihydrate to fed horses the mean AUC was 0.7 microgram.h.ml-1. The peak plasma concentrations were 4.8, 6.7, and 0.1 microgram/ml, after administration of pivampicillin to starved and fed horses and of ampicillin trihydrate to fed horses, respectively. There was no statistically significant difference in peak plasma concentration or AUC between pivampicillin administered to starved or fed horses. It is concluded that pivampicillin administered as an oral paste at a dose of 19.9 mg/kg gives satisfactory plasma concentrations in both starved and fed horses, whereas ampicillin trihydrate produces negligible plasma concentrations. Pivampicillin binds to feedstuffs at the pH found in the horse's stomach and small intestine. After incubation for 6 h at pH 6, approximately 15% remains in solution, and after incubation for 3 h at pH 1.9, approximately 40% remains in solution. Ampicillin, which binds to feedstuffs to a lesser extent, has a lower bioavailability than pivampicillin. Therefore, binding to feedstuffs does not seem to be a critical factor in the absorption of aminopenicillins.

Administration, Oral↗
PubMed1981

The oral absorption of ampicillin, pivampicillin and amoxycillin in infants and children.

The oral absorption of comparable doses of mixtures of ampicillin, amoxycillin and pivampicillin was studied in 38 children from 6 months to 6 years of age. Plasma concentrations following pivampicillin and amoxycillin were higher than those following the administration of ampicillin. No significant difference was found between amoxycillin and pivampicillin. The oral absorption of pivampicillin mixture was further studied in 12 infants, 0-1 month and 1-5 months of age. The absorption was faster in infants and children more than 6 months of age than in the 1-5 months group. The excretion, indicated by the slope of the plasma concentration curve, was delayed in infants less than one month of age. The oral absorption of amoxycillin and pivampicillin from tablets was also studied in 12 infants and children, 6 months-6 years of age, in the same doses as when mixtures were studied and was more complete with pivampicillin than with amoxycillin. The absorption of pivampicillin was more complete from tablets than from mixture. Also with amoxycillin there was a trend towards more efficient absorption from tablet than from mixture.

Absorption↗
PubMed1980

A comparison of two different dosages of pivampicillin and doxycycline in patients with gynaecological infections.

The efficacy of 500 mg pivampicillin twice daily, 350 mg pivampicillin 3-times daily and 100 mg doxycycline daily was compared in 106 patients with salpingitis, parametritis or endometritis. Both the pivampicillin regimens were equally effective. The average duration of therapy needed to produce a satisfactory clinical response was shorter with pivampicillin (14 days) than with doxycycline (21 days). Pivampicillin improved the patients' gynaecological status in 90% of the subjects treated compared to only 70% of patients given doxycycline. Fewer relapses were recorded in women given pivampicillin (4%) than in subjects treated with doxycycline (15%). Gonococci were isolated from 10% of vaginal swabs. The involvement of Chlamydia and Mycoplasma was not studied. However, the high cure rate indicated that, if present, they did not pose a therapeutic problem. Side-effects, mainly dyspepsia, were observed in 2 patients in each group. The twice-daily administration of pivampicillin is recommended, since it is more practical and increases patient compliance.

Adult↗
PubMed1991

Helicobacter pylori: treatment with combinations of pivampicillin and tripotassium dicitrato bismuthate.

Fifty Helicobacter pylori- (H. pylori) positive patients entered an open study and were assigned to one of four treatment regimens comprising: pivampicillin (500 mg b.d.) for 2 weeks +/- tripotassium dicitrato bismuthate (tablet or liquid form) for one month. The 14C-urea breath test was used to evaluate clearance (negative at the end of treatment) and eradication (negative at 1 month post-treatment) of H. pylori. Clearance rates were 20% (2/10) after pivampicillin alone, 86% (12/14) after tripotassium dicitrato bismuthate tablets (240 mg b.d.) plus pivampicillin, 67% (6/9) after tripotassium dicitrato bismuthate tablets (120 mg q.d.s.) plus pivampicillin, and 100% (13/13) after tripotassium dicitrato bismuthate liquid (120 mg in 5 ml q.d.s) plus pivampicillin. The eradication rates were 0% (0/10), 13% (2/15), 0% (0/11) and 54% (7/13), respectively. Combination of the results from the 2 tripotassium dicitrato bismuthate tablet/pivampicillin groups gave an eradication rate of 7.7% (2/26) which was significantly lower than the 53.9% (7/13) obtained with tripotassium dicitrato bismuthate liquid/pivampicillin (P less than 0.02). In conclusion, a liquid tripotassium dicitrato bismuthate pivampicillin combination may be of special use in the treatment of H. pylori-positive patients when triple therapy is contraindicated (e.g. patient sensitivity/allergy to metronidazole) or when the H. pylori isolate is resistant to metronidazole.

Adult↗
PubMed1986

A comparative study of amoxycillin and pivampicillin in persistent Haemophilus influenzae infection of the lower respiratory tract in children with chronic lung disease.

A double-blind cross-over study was undertaken to compare the efficacy of amoxycillin and pivampicillin on Haemophilus influenzae infection of the lower respiratory tract in children. 20 patients with cystic fibrosis (CF) or chronic obstructive pulmonary disease (COPD) due to other causes were included in the study. All patients had a history of regularly harbouring H. influenzae in sputum and repeated treatment failures with pivampicillin. 18 completed two 14-day courses in random order with equimolar doses of pivampicillin (80 mg/kg/day) and amoxycillin (62 mg/kg/day). Both drugs were well tolerated with no serious side effects, but pivampicillin was associated with more pronounced nausea. In steady state the mean serum concentrations of antibiotics 2 and 4 h after medication were 9.7 and 3.7 micrograms/ml for pivampicillin and 19.1 and 7.9 micrograms/ml for amoxycillin (p less than 0.01). Eradication of H. influenzae and clinical improvement was seen in one-third of the courses with both drugs. Betalactamase producing ampicillin-resistant strains emerged during 58% of the amoxycillin courses, but only in 16% of the pivampicillin courses (p less than 0.001). The high number of treatment failures and the development of resistant strains indicate that betalactamase inhibitors may possibly improve the efficacy of these drugs, especially of amoxycillin, in these patients.

Adolescent↗
PubMed2000

A follow-up study of birth outcome in users of pivampicillin during pregnancy.

BACKGROUND: Pivampicillin is a prodrug which is widely used in Scandinavian countries for oral antibiotic therapy. The pivaloyl moiety has a carnitine depleting effect, which has caused doubts about the safety of administering pivampicillin during pregnancy. The aim of the study was to evaluate the risk of congenital malformations in general, preterm delivery and low birth weight in users of pivampicillin. METHODS: Seven hundred and ninety-one women who had redeemed a prescription of pivampicillin during their first pregnancy from 1 January 1991 to 31 December 1996 were identified in the North Jutland Pharmaco-Epidemiological Prescription Database. By linkage to the Danish Medical Birth Registry and Regional Hospital Discharge Registry we compared their birth outcomes (malformations, preterm delivery and low birth weight) with the outcomes in 7472 reference pregnancies on which the mother had not redeemed any prescription at all during pregnancy. RESULTS: The prevalence of malformations was 5.5% (11 cases) in offspring of 199 women who had used pivampicillin during the first trimester, and 5.6% (420 cases) in offspring of controls (OR: 0.95, 95% CI: 0.51-1.76). Furthermore, we did not find any significant risk of preterm delivery (OR: 0.75, 95% CI: 0.54-1.05) or low birth weight (OR: 0.93, 95% CI: 0.55-1.57). CONCLUSION: This study showed no increased risk of congenital malformations, preterm delivery or low birth weight in offspring of women who had redeemed a prescription for pivampicillin during pregnancy.

Abnormalities, Drug-Induced↗
PubMed1999

A double-blind, randomized, controlled multicentre study to compare the efficacy of ciprofloxacin with pivampicillin as oral therapy for epididymitis in men over 40 years of age.

OBJECTIVE: To compare the efficacy and safety of ciprofloxacin 500 mg orally twice daily with pivampicillin 700 mg orally twice daily for 10 days in men with acute epididymitis and over 40 years of age. PATIENTS AND METHODS: The study comprised 172 men who entered a prospective, controlled, randomized, double-blind, trial of pivampicillin and ciprofloxacin. The median (range) age of the 158 patients eligible for the efficacy analysis was 58 (41-85) years; 41% had previously had a urinary tract infection and 27% had previously had epididymitis. Only one patient had a urethral catheter and 38% were sexually active. About half of the patients were admitted to hospital. RESULTS: No bacteria could be cultured from samples in 53% of the patients; Escherichia coli could be cultured from 35% and the remaining isolates were the expected urinary pathogens. None of the patients had Gonococci and only one in each group had Chlamydia. Mycoplasma hominis was detected in three patients only and M. genitalium was detected in three, while Ureaplasma was detected in 24 (15%). The treatment failed in 48 patients; in 15 of 76 (20%) receiving ciprofloxacin and in 33 of 82 (40%) receiving pivampicillin. This corresponds to a reduction in the risk of failure of 20.5% (95% confidence limits 6.6-40.2%, P=0. 006). The principal cause of failure was an unsatisfactory clinical response requiring changed antibiotic treatment in 27 patients; adverse events were responsible for failure in 14. The in vitro resistance of cultured bacteria was low in both groups, at approximately 4%. Adverse events, mainly gastro-intestinal, occurred in 17 of 83 (21%) patients starting on ciprofloxacin and in 33 of 89 (37%) receiving pivampicillin (P=0.04). CONCLUSION: For epididymitis in men over the age of 40 years ciprofloxacin 500 mg orally twice daily is more effective than pivampicillin 700 mg orally twice daily. Furthermore, ciprofloxacin has a lower incidence of adverse events.

Administration, Oral↗
PubMed1979

A gastroscopic and pharmacological study of the disintegration time and absorption of pivampicillin capsules and tablets.

1 An in vitro investigation showed that pivampicillin tablets disintegrated more rapidly than pivampicillin capsules. This result was demonstrated and confirmed by gastroscopy in a cross-over study in healthy volunteers. 2 There were no differences in serum levels of ampicillin obtained with the two preparations, but compared with non-gastroscoped volunteers, there was delay of 0.5--1.5 h in the appearance of peak serum ampicillin concentrations after gastroscopy. 3 Half of the volunteers receiving pivampicillin capsules developed hyperaemia, interstitial bleeding or erosions of the gastric mucous membrane. No such reactions were seen after pivampicillin tablets. 4 In one volunteer, a pivampicillin capsule was trapped in a not previously noticed hiatus hernia and local changes and pain occurred.

Adult↗
PubMed1992

Bioavailability of oral penicillins in the horse: a comparison of pivampicillin and amoxicillin.

The pharmacokinetics of ampicillin and amoxicillin following intravenous administration at a dose rate of 15 and 10 mg/kg respectively were studied in four healthy adult horses. Pharmacokinetics of pivampicillin and amoxicillin were studied after oral administration to four healthy adult horses. Pivampicillin, a prodrug of ampicillin, was administered orally to starved and fed horses at a dose rate of 19.9 mg/kg, which is equivalent on a molecular basis to 15 mg/kg ampicillin. Amoxicillin was administered orally to starved horses only, at a dose rate of 20 mg/kg. Ampicillin and amoxicillin concentrations in plasma, synovial fluid and urine were determined. Mean biological half-life of intravenously administered ampicillin and amoxicillin was 1.72 and 1.43 h respectively, whilst the distribution volume (Vss) appeared to be 0.180 and 0.192 1/kg. Orally administered pivampicillin and amoxicillin were rapidly absorbed. A maximum concentration in plasma of 3.80 micrograms/ml was reached 2 h after administration of pivampicillin to starved horses; in fed horses a maximum concentration of 5.12 micrograms/ml was reached 1 h after administration. After oral administration of amoxicillin a maximum concentration of 2.03 micrograms/ml was reached after 1 h. The (absolute) bioavailability of pivampicillin administered orally was 30.9% in starved horses and 35.9% in fed horses. The bioavailability of amoxicillin administered orally was 5.3% in starved horses.

Administration, Oral↗
PubMed1988

Pivampicillin compared with erythromycin for treating women with genital Chlamydia trachomatis infection.

In a randomised single blind study, pivampicillin was compared with erythromycin in women with urogenital Chlamydia trachomatis infections. The pivampicillin dosage was 700 mg twice a day and the erythromycin dosage 500 mg twice a day for seven days. Follow up took place on days 7 and 14 after the start of treatment. All 26 women treated with pivampicillin were culture negative for chlamydiae at the first and second follow up visits. All 23 women who received erythromycin were culture negative at the first follow up visit, but one was culture positive at the second follow up visit. Gastrointestinal side effects were recorded in five patients receiving pivampicillin and in nine receiving erythromycin. Two patients receiving erythromycin were withdrawn from treatment because of gastrointestinal disturbances, compared with none receiving pivampicillin.

Adolescent↗
PubMed1991

Treatment of bacterial vaginosis with metronidazole or pivampicillin.

In a double-blind randomized controlled trial from general practice, we assessed the efficacy of treatment with either metronidazole or pivampicillin in patients fulfilling the diagnostic criteria of bacterial vaginosis. 50 women were treated with metronidazole 500 mg twice daily and 54 with pivampicillin 700 mg twice daily, both for seven days. Evaluated four weeks after the start of treatment, we found a significantly higher cure rate in the metronidazole group (90%) than in the pivampicillin group (69%) (p = 0.01). Cure was defined as lack of fulfillment of the diagnostic criteria of bacterial vaginosis. Test for confounding according to parity and complaint of vaginal discharge showed no influence. Side-effects were significantly commoner in the pivampicillin group (28%) than in the metronidazole group (8%). We consider that metronidazole is a potent drug in the treatment of bacterial vaginosis, with pivampicillin as a useful alternative.

Adolescent↗
PubMed1975

[The effect of pivampicillin and probenecid on experimental syphilis in rabbits].

The oral single-dose-treatment of the acute gonorrhoeal urethritis of the male with 1.4 g pivampicillin and 1.0 g probenecid is one of the possible alternatives to a parenteral penicillin treatment. Experiments were performed on rabbits to determine if this dose of pivampicillin and probenecid could cure a simultaneously acquired syphilis at a very early stage of incubation. 300 treponems (Nichols strain, T. pallidum) were inoculated intratesticularly and 3 days later pivampicillin and probenecid were administered in doses which produced antibiotic serum levels similar to those in patients who had received a single oral dose of 1.4 g pivampicillin and 1.0 g probenecid. Controls over a 15-weeks period showed that this dosage did prevent the development of syphilitic orchitis and reactivity to the quantitative FTA-ABS-test. It is concluded that the treatment of acute gonorrhoea with 1.4 g pivampicillin and 1.0 g probenecid in general is sufficient to cure a simultaneously acquired syphilis.

Administration, Oral↗
PubMed1983

Tolerance of two ampicillin esters: a comparison of pivampicillin and bacampicillin.

The tolerability of tablets containing the ampicillin esters, pivampicillin and bacampicillin were compared clinically in 138 patients and by gastroscopy in 2 healthy volunteers. The clinical study showed no difference in tolerability, 26% of patients taking pivampicillin and 23% of those taking bacampicillin reported side-effects. Both preparations were equally effective clinically: 94% of patients taking pivampicillin and 91% of those taking bacampicillin were cured or improved. Gastroscopy showed that the pivampicillin tablets disintegrated more rapidly (10 minutes) than bacampicillin tablets (36 minutes). After disintegration, the pivampicillin tablets covered a larger area of the gastric mucosa than did tablets of bacampicillin.

Adolescent↗