Open study on efficacy and tolerability of ciprofloxacin XR compared with ciprofloxacin BID in the treatment of typhoid fever.

AIM: To compare the efficacy and tolerability of ciproflaxin extended-release and ciproflaxin intermediate release in the treatment of typhoid fever. METHODS: A prospective, open labelled, clinical trial, comparing the safety and efficacy of extended-release ciprofloxacin 1000 mg once daily (Ciprofloxacin XR) and ciprofloxacin intermediate release 500 mg two times daily (Ciprofloxacin bid) was performed in adult with typhoid fever. Diagnosis for typhoid fever was based on Widal serology test, blood culture and Polymerase Chain Reaction (PCR) for Salmonella typhi. A two-sided student t-test and chi-square or Fisher's exact test were used for the analysis of clinical responses. RESULTS: Good clinical responses were obtained in 32 subjects (14 with Intermediate release ciprofloxacin and 18 with Extended-release ciprofloxacin) and there were no failure case (0%). Day to reach defervescence in Ciprofloxacin BID (mean 3.28 days) was similar to Ciprofloxacin XR group (mean 3.72 days) with p=0.43. Mild side effects were noted in 7.1% of subjects who received Ciprofloxacin BID compared by 22.2% in subjects who received Ciprofloxacin XR, with p=0.29. There were no moderate or severe side effects on both drugs. CONCLUSION: Clinical outcomes were similar for the two treatments and both treatments were well tolerated. Once daily ciprofloxacin XR was safe, effective, and non-inferior to twice-daily ciprofloxacin IR in the treatment of typhoid fever.

The prevalence of hypokalemia in hospitalized patients with infectious diseases problem at Cipto Mangunkusumo Hospital, Jakarta.

AIM: to know the prevalence of hypokalemia that occurs in hospitalized patients with infectious diseases. METHODS: a cross sectional study was carried out in the internal ward Cipto Mangunkusumo General Hospital in Jakarta from December 2005 until June 2006. All hospitalized patients with infectious diseases receiving "replacement solution" were included in this study. We collected the blood sample to perform the serum potassium level at the time of admission and discharge. RESULTS: one hundred and five patients were enrolled in this study; consisting of 44 males and 61 females. The age ranged from 14 to 70 years old. The most common infectious diseases were dengue fever, while the underlying diseases were hepatobiliary disorders. "Replacement solutions" which were given, were ringer's lactate 91%, normal saline 8%, and ringer's acetate 1%. Prevalence of hypokalemia among the hospitalized patients, on admission was 24 patients (23%) and during hospitalization was 39 patients (37%). The mean level of hypokalemia on admission was 3.11 + SD 0.37 mEq/L (range from 1.7 to 3.4 mEq/L) and during hospitalization was 3.13 + SD 0.25 mEq/L (range from 2.5 to 3.4 mEq/L). On admission, the ratio of mild : moderate : severe hypokalemia is 22 : 2 : 1. And at discharge the ratio of mild to moderate hypokalemia becomes 19 : 6. CONCLUSION: the prevalence of hypokalemia in hospitalized patients with infectious disease in Cipto Mangkunkusumo's Hospital, Jakarta is 23%. Further studies are needed to know the contributing factors including the usage of 'intravenous fluid' in relations to hypokalemic state during hospitalization.

Open study on efficacy and safety of levofloxacin in treatment of uncomplicated typhoid fever.

The main objective of this study was to determine the clinical efficacy and safety of levofloxacin in an open setting for typhoid fever cases. Patients with clinical signs and symptoms of typhoid fever without previous antimicrobial treatment admitted to affiliated hospitals of the Faculty of Medicine, University Indonesia were included in this study. Adults, 18 years or above, were screened for any serious underlying conditions, pregnancy or possible complications of typhoid fever before final enrollment. Fifty-three subjects were screened, 48 were enrolled. The final diagnosis of enteric fever was made by positive blood culture, polymerase chain reaction or serology, was obtained in 31 cases, in whom one had a concomitant sinus infection and had to be excluded. Thirty patients (11 males, 19 females) aged between 18-58 years (mean 31.7 years) with a history of fever between 1 and 10 days (mean 6.1 days) showed excellent clinical response, becoming afebrile at an average of 2.43 days (range 1-5 days). Adverse effects noted were nausea in 4 patients, vomiting in one and meteorism in another one, which were all difficult to distinguish from the enteric infection. A pruritic rash occurring in two patients may be related to levofloxacin, and insomnia in another patient may be related. Microbiological clearance was obtained both immediately after treatment and at one month. No carrier states were detected in the cases positive for Salmonella typhi or paratyphi. None of the treated typhoid fever cases experienced a clinical relapse. In this open study of levofloxacin 500 mg/day for one week in treatment of uncomplicated typhoid fever, a 100% clinical efficacy was obtained in 30 patients with minimal adverse reactions warranting more intensive studies for this new indication of an old but well known disease in the developing world.