Tolerability of long-term malaria prophylaxis with the combination mefloquine + sulfadoxine + pyrimethamine (Fansimef): results of a double blind field trial versus chloroquine in Nigeria.

A randomized double blind study in long term malaria chemoprophylaxis was performed to compare the tolerability of Fansimef (1 tablet containing 250 mg mefloquine + 500 mg sulfadoxine + 25 mg pyrimethamine per week) with chloroquine (300 mg per week). 211 Austrian industrial workers and their families in Warri, Nigeria, participated in this study; 101 received Fansimef and 110 chloroquine for 3-18 months (mean 41 weeks). Prophylaxis was discontinued because of adverse effects in 7 volunteers in the Fansimef group (mainly insomnia, palpitations, dizziness, nausea and headache) and in 2 volunteers of the chloroquine group (headache and loss of hair in one volunteer, nausea, dizziness and vomiting in the other). Most of the adverse effects could be due to the mefloquine component. A few minor complaints of burning eyes, nausea and gastric pain were reported in both groups. Laboratory checks performed at 3-monthly intervals showed a slight, transient and clinically irrelevant (but statistically significant) increase of serum glutamic-oxalacetic transaminase and gamma-glutamyl transpeptidase at month 3 in the Fansimef group. An attack of acute Plasmodium falciparum malaria occurred in one volunteer 6 weeks after discontinuation of prophylaxis with Fansimef. Antibodies against blood stage parasites could be demonstrated by the indirect immunofluorescence test at different stages of the study, indicating that these two antimalarials are not causal prophylactic agents.

Electron microscopy and the polymerase chain reaction of spirochetes from the blood of patients with Lyme disease.

Results of studies using direct antigen detection suggest that seronegative Lyme borreliosis is not rare and support the hypothesis that Borrelia antigens can persist in humans. We report three successful cultures from blood out of 30 attempts from 96 Lyme disease patients. The proof of borreliaemia in early or late phases of Lyme disease by immuno-capture electron microscopy has practical importance for subsequent cultivation. The polymerase chain reaction with oligonucleotide sequences directed against 16S rRNA identified two of our blood isolates as Borrelia burgdorferi genospecies III., VS 461 group, and one as Borrelia garinii sp. nov. All of the three isolates were reactive with monoclonal antibody H9724 against flagellin and with antibody against main extracellular protein at 83 kDa. Borrelia garinii had a single predominant protein OspA at 33.5 kDa and reacted with monoclonal antibody H5332 in contrast to two isolates of the VS 461 group with two major proteins OspA and OspB at 32.5 and 35 kDa. We conclude that isolation of spirochetes from the blood might prove successful in clinically selected cases of Lyme borreliosis. Immuno-capture electron microscopy has proved to be a sensitive assay for monitoring and studying Lyme borreliosis.

In-vitro activity of fleroxacin.

Fleroxacin is a new synthetic fluorinated quinolone antimicrobial agent. The in-vitro activity of fleroxacin and five comparative quinolones against 541 clinical isolates was studied. Minimum inhibitory concentrations (MIC90) of fleroxacin were less than or equal to 2.0 mg/l for Enterobacteriaceae, less than or equal to 8.0 mg/l for Pseudomonas aeruginosa and 1.0 mg/l for Acinetobacter calcoaceficis and 8 mg/l for streptococci. The activity of fleroxacin was comparable with that of ofloxacin, pefloxacin and norfloxacin, but less than that of ciprofloxacin. All quinolones showed little difference between MIC and minimum bactericidal concentrations (MBCs).

Ceftriaxone in the treatment of Lyme neuroborreliosis.

In an open non-comparative clinical trial with the aim of evaluating the clinical efficacy and safety of a 14 day course of 2 g ceftriaxone once daily, 46 patients with neuroborreliosis were entered at the Infectious Diseases Teaching Hospital in Prague 8. In 39 patients the diagnosis was early Lyme neuroborreliosis. Seven patients suffered from late stage disease. Clinical results were 30% of patients cured at the end of treatment and 85% after 9 months in early stage disease. In late stage disease two patients out of seven were cured and four had improved after 12 months. One patient died because of cardiac infarction. In no patient had treatment to be discontinued because of adverse reactions to antibiotics.

Quinolones as an alternative treatment of chlamydial, mycoplasma and gonococcal urogenital infections.

We report the results of several trials aimed at evaluating the quinolones in urogenital infections. In Chlamydia trachomatis infections, ofloxacin (200 mg b.i.d. for 10 days) gave a cure rate of 98% (n = 66), and fleroxacin (400 mg s.i.d. for 7 days) provided a cure rate of 89% (n = 19). A double-blind study comparing fleroxacin (600 mg s.i.d.) to doxycycline (100 mg b.i.d.) for 7 days showed similar high cure rates for both regimens (100%; n = 23). In Mycoplasma hominis infections, ofloxacin (200 mg b.i.d. for 10 days) yielded a cure rate of 86% (n = 50) for M. hominis and 55% (n = 43) for Ureaplasma urealyticum. Gonococcal infections (n = 122) were all cured by a single dose of 200 mg ofloxacin. Both ofloxacin and fleroxacin were well tolerated and may be recommended for patients with chlamydial or uncomplicated gonococcal infections, although 600 mg fleroxacin showed a higher incidence of adverse events compared to doxycycline.