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Biomedical subjects

D Stürchler

Publications and source records attributed to D Stürchler.

At least 37 records · Page 2Linked to original sources
PubMed1993

Treatment of travellers' diarrhoea with fleroxacin: a case study.

A double-blind, randomized, placebo-controlled trial was conducted to evaluate the efficacy and safety of fleroxacin for one or two days as treatment for patients with travellers' diarrhoea. A total of 195 patients who were suffering with acute diarrhoea of less than six days' duration were enrolled. One hundred and fifty-one patients, of whom 49 received placebo, 54 received fleroxacin 400 mg for one day and 48 received fleroxacin 400 mg for two days, were included in the analysis of efficacy. The results showed that fleroxacin was significantly superior to placebo, but that there was no significant difference in terms of efficacy between the one- and two-day regimens. Adverse events, particularly minor neuropsychiatric disturbances such as headache and insomnia, were significantly more common amongst patients receiving active treatment. In conclusion, a single dose of fleroxacin 400 mg could be recommended as self-treatment for visitors to high-risk countries who develop travellers' diarrhoea.

Adult↗
PubMed1993

How frequent are notified severe cutaneous adverse reactions to Fansidar?

An attempt was made to estimate the risk of severe cutaneous adverse reactions (SCARs) to Fansidar (sulfadoxine plus pyrimethamine). Cases were identified through a spontaneous reporting system. Persons exposed were estimated using sales data of 27 countries reporting one SCAR case for either Fansidar or a related product, Bactrim (cotrimoxazole; sulfamethoxazole plus trimethoprim). Between 1974 and 1989, 126 cases were notified for Fansidar: 87 cases of erythema multiforme or Stevens-Johnson syndrome, and 39 cases of toxic epidermic necrolysis. 86% of cases were reported in Europe or North America. In 116 cases with use known, prophylaxis was the reason in 103, and treatment in 13. Toxic epidermolysis and erythema multiforme/Stevens-Johnson syndrome had case fatalities of 36 (95% confidence intervals 21 to 53%) and 9% (4 to 18%), respectively. Fansidar users were estimated at 117 million, and the overall SCAR risk to be 1.1 (0.9 to 1.3) per million. For developing countries with mainly single dose use, the risk was estimated to 0.1 (0.0 to 0.1) per million. For Europe and North America with mainly prophylactic use, the risk was 10 (8 to 12) and 36 (23 to 48) per million, respectively. Prophylactic use had a 40 times higher risk than single dose therapeutic use. The aggregated risk peaked in 1984-1985, with global and North American SCAR frequencies of 3.4 (2.4 to 4.3) and 72 (41 to 102) per million, respectively. After 1985, North America reported only one further case despite continued use by an estimated 0.3 million persons.(ABSTRACT TRUNCATED AT 250 WORDS)

Adverse Drug Reaction Reporting Systems↗
PubMed1993

Prevention of Plasmodium falciparum malaria by Fansimef and Lariam in the northeastern part of Thailand.

Two studies were conduct in Thailand in order to find appropriate falciparum malaria prophylactic drug regimens. The first study was done during June - September 1987 with 363 soldiers who received Fansimef (MSP) 1 tab/week (group 1), 337 soldiers who received MSP 1 tab/2 week (group 2) and 165 soldiers who received chloroquine 300 mg base weekly plus Fansidar 1 tab/week (group 3). At the end of the study there were 9 and 13 falciparum malaria episodes in groups 1 and 2, respectively, with incidence rates of 0.8 and 1.8 cases/100 person-months (P-M). In group 3, the corresponding values were 30 episodes and an incidence of 7.2/100 P-M. For the second study which lasted from October 1987 - January 1988 in the same area, 498 soldiers were given Fansimef 1/2 tab/week (group 4), 499 soldiers were given Lariam 1/2 tab/week (group 5) and 247 soldiers were given chloroquine plus Fansidar (group 6). Thirty malaria episodes were found in group 4, for an incidence of 2.0/100 P-M. In group 5, 23 episodes were found, for an incidence of 1.6/100 P-M. In group 6, 74 episodes occurred, ie an incidence of 12.2/100 P-M. The incidence rates of malaria among Fansimef 1 tab weekly, Fansimef half dose weekly or Lariam half dose weekly were not significantly different but were different from chloroquine plus Fansidar groups. Adverse events in each group were mild.

Adult↗
PubMed1993

Commitment of Roche in malaria and other tropical diseases.

In the absence of a suitable malaria case definition, reliable surveillance data on the impact of malaria are not available. Determinants of case loads, including population movements, environmental changes, lack of political commitment and resources, and resistance to antimalarials and residual insecticides, work towards global deterioration. Some 90% of the Plasmodium falciparum burden is carried by Africa south of the Sahara. There, in 1992, the number of children under five years of age and exposed to high risk was about 106 million. Assuming a malaria attack rate of 0.5-1.5 per child per year, and a case fatality rate of 2%, annual clinical cases and malaria deaths in this population alone come to 53-160 million and 1-3 million, respectively. Roche, a pharmaceutical company with major research efforts in tropical medicine, in collaboration with research centers and international institutions, has recently set up a tropical medicine unit that coordinates and concentrates corporate efforts in this field. The unit aims to make affordable and innovative products available which are effective against major tropical diseases. A commercial product of the unit is Lariam, a major antimalarial used alone or in simultaneous or sequential combinations. The single dose combination of Lariam plus Fansidar (Fansimef) is particularly useful for stand-by or emergency oral therapy. Artemisinine, or its derivatives, followed by one to two doses of Lariam are effective against severe and multiresistant P. falciparum malaria. A new Roche peroxide antimalarial is currently in phase II clinical trials. The unit is also involved in research and development of malaria sporozoite and asexual blood stage vaccine candidates.

Africa↗
PubMed1993

Comparative tolerability and kinetics during long-term intake of Lariam and Fansidar for malaria prophylaxis in nonimmune volunteers.

One hundred and five healthy nonimmunes in Colombia took part in a randomize, double-blind comparison of 250 mg of Lariam (L) (active ingredient: mefloquine) on alternate weeks or one tablet of Fansidar (F) (active ingredients: sulfadoxine and pyrimethamine) weekly for malaria prophylaxis during at least six months. Volunteers also gave blood for determination of drug concentrations after six months and/or 24-27 months of prophylaxis. Twenty-five volunteers withdrew involuntarily when they lost their jobs in the company. Two who took L withdrew due to moderate diarrhea and mild nausea or headache, weakness, drowsiness and anxiety. One volunteer stopped taking F due to severe unilateral hypostatic eczema and slight S-T depressions on the ECG. The rest completed at least six (range 6-36) months of prophylaxis. The mean half-life for L was 26 days. The AUCs in the time interval 0-14 days for L varied between 19.3-31.5 mumol x days/l. For the main metabolite, the corresponding range was 28.8-81.3 mumol x days/l. The range of trough concentrations at day 0 and 14 were 0.95-2.01 mumol/l for L and 1.69-5.62 mumol/l for the metabolite. No differences in tolerability and efficacy were noted between L and F. Our kinetic results do not indicate that enzymatic induction or inhibition would be important during long-term prophylaxis with mefloquine. This favors a continued use of the drug for very long periods of time (= years).

Adult↗
PubMed1992

Mefloquine-sulphadoxine-pyrimethamine (Fansimef, Roche) in the prophylaxis of Plasmodium falciparum malaria: a double-blind, comparative, placebo-controlled study.

From July 1987 to June 1988 a randomized, double-blind, comparative placebo-controlled field trial was conducted in a group of villages near Ibadan, Nigeria. The aim of the study was to assess the suppressive tolerability and efficacy of four antimalarials (Fansimef, Lariam, Fansidar, chloroquine) given for 24 weeks. Fansimef and Lariam were given with loading and maintenance doses, Fansidar and chloroquine as one tablet per week for 24 weeks. Of 567 enrolled subjects, 114 (20%) had parasitaemia on entry. Eight episodes of symptomatic falciparum malaria occurred during the trial, seven in the placebo group, and one in the Fansimef group. Compared with placebo, parasitaemia was effectively suppressed by all four drug regimens. Adverse event data were not significantly different between groups: six adverse events per 114 participants in the Fansimef group, six/113 in the mefloquine group, five/111 in the Fansidar group, 17/115 in the chloroquine group and eight/114 in the placebo group. Safety of Fansimef for 24 weeks in endemic areas was comparable for standard antimalarials in this trial and provides support for the use of this drug for the treatment of resistant malaria in indigenous African populations.

Adolescent↗
PubMed1992

Cord blood screening for congenital toxoplasmosis: detection and treatment of asymptomatic newborns in Basel, Switzerland.

Cord blood screening is a helpful tool for the detection of infants probably infected with Toxoplasma gondii, if serological data of the mothers are not available. Testing for toxoplasma specific IgM and IgG antibodies of about 30,000 cord blood sera gave information about the changes in prevalence and incidence of toxoplasmosis in pregnant women in Basel between 1983 and 1991. The follow up and treatment of the infected children revealed the need of a randomized study comparing high and low dose treatment schedules.

Adolescent↗
PubMed1992

Evaluation of 5.1-[NANP]19, a recombinant Plasmodium falciparum vaccine candidate, in adults.

In a randomized single-blind study, 13 healthy adult volunteers were subcutaneously immunized with 2 or 3 single 50 or 400 micrograms doses of a Plasmodium falciparum recombinant vaccine candidate designated 5.1-[NANP]19. The vaccine caused transitory reactions at the injection site. Eight (62%) volunteers had a greater than or equal to 4-fold increase of antibody titer against sporozoites in immunofluorescence assay, all 13 seroconverted in IgG enzyme-linked immunosorbent assay against [NANP]50 antigen, and in 6 (46%) a lymphocyte proliferation index greater than or equal to 3 against 5.1 antigen was observed. Seven volunteers were challenged with mosquitoes infected with P. falciparum. All developed detectable parasitemia after 7 to 12 days and all received drug therapy within 24 hours. One volunteer with a cellular response to 5.1 had two negative in vitro parasite cultures before treatment, despite overt parasitemia. He was the only challenged volunteer who remained free of malaria symptoms.

Adult↗
PubMed1991

[An unusual case of imported malaria].

We report a case of malaria occurring after a journey to Guadeloupe, an island, which is considered as being free of malaria. The case report serves to remind that previous areas of endemicity remain receptive for malaria, and that one has to consider malaria in the differential diagnosis of a feverish illness even when a traveller returns from a country where malaria transmission has not been reported.

Animals↗
PubMed1991

[Current drugs for the treatment of tropical malaria].

The occurrence in the early 60's of stable resistance to chloroquine among Plasmodium falciparum strains in the Amazonas and on the Thai-Cambodian border has been a shock for all malariologists. This led to the search for new antimalarials without cross resistance with chloroquine. For each new drug, one of the major concerns was to define how rapidly parasites would develop resistance to this compound. Drug combinations were taken into consideration so as to achieve a delay in the appearance of resistance. The decision to test a triple combination has led to the development of Fansimef, a fixed combination with tablets containing 250 mg mefloquine, 500 mg sulfadoxine and 25 mg pyrimethamine. A very relevant delay in the development of resistance was found both in-vivo--in the P. berghei model--and in-vitro using P. falciparum. Fansimef has also been under investigations for malaria. Controlled clinical trials were performed in Africa, South America and South East Asia. The documentation for this new indication will be submitted to registration authorities in 1991. A preference alternative to continuous chemoprophylaxis is stand-by malaria treatment for travellers to regions where the malaria risk is relatively low. Stand-by treatment is under investigations in France and in Switzerland. In the search for alternative remedies against drug resistant P. falciparum malaria our attention was directed to Yingzhaosu, a new sesquiterpene peroxide of plant origin from traditional Chinese medicine. A short and convenient synthesis of this ring system gave access to a variety of structural analogues of Yingzhaosu.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1991

Cloned antigens from Plasmodium falciparum as malaria vaccine candidates.

The problems of genetic polymorphism and poor immunogenicity of malaria vaccine candidates are discussed, with emphasis on the Circumsporozoite (CS) and p190 proteins of Plasmodium falciparum. It may be possible to use conserved regions of these proteins to raise protective immune responses against non-polymorphic determinants. Better adjuvants or delivery systems will be a critical factor in development of an effective vaccine.

Amino Acid Sequence↗
PubMed1990

Interferon-alpha and synthetic peptide malaria sporozoite vaccine in non-immune adults: antibody response after 40 weeks.

Adults with no known immunity to sporozoites received, i.m., at weeks 0 and 8 two single 200 micrograms doses of a peptide Plasmodium falciparum sporozoite vaccine conjugated to tetanus toxoid ((NANP)3-TT) plus placebo (group 1) or interferon-alpha (IFN-alpha) (group 2) and were followed for antibody responses at weeks 4, 12 and 40. Peak antibody responses were observed at week 12. At week 40, a greater than or equal to 4-fold increase in antibody titre to sporozoites in IFA, or to (NANP)50 in ELISA was still detectable in 6 of 12 (50%) volunteers in group 1 and in 16 of 25 (64%) in group 2. Peak antibody titres in IFA and ELISA decreased with a rate of 0.8% and 0.5% per week, respectively.

Animals↗
PubMed1989

Effects of interferons on immune response to a synthetic peptide malaria sporozoite vaccine in non-immune adults.

A Plasmodium falciparum sporozoite vaccine, composed of a synthetic dodecapeptide (NANP)3 coupled to tetanus toxoid (TT), was injected, at weeks 0 and 8, into non-immune volunteers in two randomized double-blind placebo-controlled trials. In the first trial, 37 volunteers received the vaccine simultaneously with placebo (group 1), 0.5 x 10(6-) (group 2), or 1.5 x 10(6) U (group 3) of recombinant human interferon-alpha (= IFN-alpha). In the second trial, 35 other volunteers received the vaccine with placebo (group 4), 0.25 x 10(6) (group 5), or 1.0 x 10(6) IU (group 6) of interferon-gamma (= IFN-gamma). Immunizations were well tolerated and resulted in seroconversion rates (greater than or equal to 4-fold increase of antibody titre in immunofluorescence or enzyme-linked immunosorbent assays) of 67-100% of volunteers. IFN-alpha significantly enhanced the IgG antibody titres in ELISA to malaria peptide.

Adjuvants, Immunologic↗