Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objective: Primary Outcome/Efficacy Variable:
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1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: MAL30013 Title: An Open-Label Comparative Study to Determine the Safety and Efficacy of MALARONE (Atovaquone and Hydrochloride) Versus in the Treatment of Acute Plasmodium falciparum Malaria in Children Weighing 5 and <11kg in Gabon Rationale: Malarial infection is one of the most significant causes of morbidity and mortality in the tropical and sub-tropical parts of the world. Malaria is caused by infection with one or more of the four species of the genus Plasmodium (P. vivax, P. ovale, P. malariae, and P. falciparum). P. falciparum is the predominant and most virulent of the malaria parasites. It is estimated that between 270 and 480 million cases of malaria occur each year in subsaharan Africa. Approximately half of these infections occur in children less than 5 years of age. In areas with the highest transmission rates, malaria mortality is focused in children and pregnant women. Atovaquone and proguanil hydrochloride (atovaquone/proguanil) acts synergistically against chloroquine sensitive and resistant strains of P. falciparum in vitro, and clinical studies have demonstrated enhanced efficacy of the combination compared to either drug alone. Previous pediatric atovaquone/proguanil studies were conducted in children weighing more than 11 kg; however, the greatest morbidity and mortality associated with malarial infection occurs in young children and infants. This study was completed to obtain additional information regarding the safety, efficacy, and population pharmacokinetics of atovaquone/proguanil in children weighing 5kg to <11kg. The study site is situated in a rain forest area on the river Ogooue in Gabon. The predominant infecting species is P. falciparum, responsible for more than 90% of all infections, together with some P. malariae and P. ovale infections. P. falciparum transmission is intense and perennial with an average entomological inoculation rate of around 50 infectious bites per person per year., a 4-aminoquinoline, was chosen as the comparator drug because it is commonly used in many African countries, including Gabon, for treating uncomplicated P. falciparum infections in Gabon. The atovaquone/proguanil dosage used for this study was based on the regimens used in previous pediatric studies; children weighing kg were treated with mg/kg of atovaquone and mg/kg of proguanil hydrochloride. dosing was based on the current standard dosing of 30 mg/kg for children in this weight group. Phase: III Study Period: 20 January December 2000 Study Design: This was a single-center, randomized, open-label, parallel-group study. Subjects were screened for eligibility, randomized (1:1) to be treated for 3 consecutive days with either atovaquone/proguanil or amodiaquine, followed by a 26 day follow-up period. Centers: The study was conducted in 1 center in Gabon. Indication: Treatment of malaria Treatment: Subjects received atovaquone/proguanil or amodiaquine chlorohydrate administered once daily by mouth for three days. Each fixed-dose pediatric strength atovaquone/proguanil tablet contained 62.5 mg atovaquone and 25 mg proguanil hydrochloride. Subjects with body weight 5 kg to <9 kg received 2 tablets/dose, while those with weight 9 kg to <11 kg received 3 tablets/dose. chlorohydrate was a 1% suspension. Objective: The primary objective of this study was to compare the efficacy of atovaquone/proguanil versus amodiaquine in the treatment of children weighing 5kg and <11kg with acute, uncomplicated P. falciparum malaria. Primary Outcome/Efficacy Variable: The primary efficacy measures were 28-day cure rate; the number or subjects with adequate clinical response [ACR], early treatment failure [ETF], and late treatment failure [LTF]);the number of subjects with and without parasitemia at the Day 1, 2, 3, 4, 8, and 29 assessments; molecular evaluation of parasite specimens by polymerase chain reaction (PCR) and single-strand conformational polymorphism (SSCP) analysis for subjects failing treatment; and determination of the WHO Response to Therapy classification. The WHO Response to Therapy classifications were the following: Sensitive (clearance of asexual parasitemia within 7 days of initiation of treatment, without subsequent recrudescence during the 28-day follow-up period) Resistant RI (clearance of asexual parasitemia as in sensitive cases, followed by recrudescence within 28 days) Resistant RII (marked reduction of asexual parasitemia, but no clearance during 7 days) Resistant RIII (no marked reduction of asexual parasitemia during the first 48 hours) Early Treatment Failure (ETF) was defined as development of danger signs or severe malaria on Day 2, 3 or 4 in the presence of parasitemia, a parasitemia count on Day 3>Day 1 or a parasitemia count on Day 4>25% of Day 1. Late Treatment Failure (LTF) was defined as development of danger signs or severe malaria after Day 4 in the 1
2 presence of parasitemia (same species and strain as on Day 1) or parasitemia on or between Day 8 and at last study visit (Day 29) (same species and strain as on Day 1) A subject was determined to have an Adequate Clinical Response (ACR) when they did not develop any of the criteria of ETF or LTF and parasitological clearance was confirmed throughout the Follow-up Period (Day 29). Secondary Outcome/Efficacy Variable(s): The secondary efficacy measures included determination of parasite clearance time (PCT) and fever clearance time (FCT). Statistical Methods: The target sample size was 200 enrolled patients to achieve approximately 180 evaluable subjects. Assuming a follow-up rate of 90% and assuming success rates (28-day cure rates) of 95% and 80% in the atovaquone/proguanil and amodiaquine groups, respectively, 100 subjects per group would give at least 80% power of detecting a difference of 15% between the groups at a 5% significance level. Subjects whose efficacy response was evaluable were included in the per-protocol (PP) population. Subjects who deviated from the protocol were excluded from the PP population. All subjects who were randomized and received at least one dose of treatment were included in the intent-to-treat (ITT) and Safety population. A summary of the numbers for each response (adequate clinical response [ACR], early treatment failure [ETF], and late treatment failure [LTF]), as well as a summary of the 28-day cure rate, was presented for both the per-protocol (PP) and intent-to-treat (ITT) populations. The difference in percentage cure rate between the treatment groups, with 95% confidence interval, was presented, and the success proportions in each treatment group were compared using Fisher s Exact Test. The following assessments were also presented: the number of subjects with and without parasitemia at each study visit, a listing and summary by treatment group by WHO criteria for classification of noncurative and responses resistant to therapy, and a listing of molecular analyses results. PCT and FCT were listed by treatment group and summarized for the PP and ITT populations. PCT and FCT were also displayed for the ITT population using Kaplan-Meier techniques. All adverse events and all drug-related AEs were listed and summarized by body system, frequency, and intensity and by action taken. All laboratory parameters and their changes from Day 1 were summarized by treatment group and visit. Study Population: The diagnosis and main criteria for inclusion were the following: Male or non-childbearing female pediatric subjects weighing 5 kg and <11 kg Documented, uncomplicated P. falciparum infection with acute manifestations (e.g., fever) Parasitemia between 1,000 and 200,000 asexual P. falciparum parasites/µl; subjects with P. malariae or P. ovale co-infection may have been included Parent or guardian willing and able to give written or verbal informed consent and comply with the study protocol Number of Subjects: Planned, N Randomized, N Per-Protocol (PP) Population, N Completed, n (%) 88 (88) 43 (43) Total Number Subjects Withdrawn, N (%) 12 (12) 57 (57) Withdrawn Due to Adverse Events, n (%) 3 (3) 3 (3) Withdrawn for Other Reasons, including Lack of Efficacy, n (%) 9 (9) 54 (54) Demographics: Females:Males 45:55 45:55 Mean Age, Months (SD) 17.2 (8.2) 17.9 (9.2) Black, n (%) 100 (100) 100 (100) Weight 5 kg to <9 kg, n (%) 28 (28) 29 (29) Weight 9 kg to <11 kg, n (%) 72 (72) 71 (71) Mean Weight, kg (SD) 9.41 (1.35) 9.51 (1.32) Primary Efficacy Results: 28-Day Cure Rate Success, n (%) 87 (87) 42 (42) Difference Between Treatments 45% 2
3 95% Confidence Interval for Difference 33, 57 p-value for Difference <0.001 Summary of Efficacy Response Adequate Clinical Response (%) 87 (87%) 42 (42%) Early Treatment Failure (%) 2 (2%) 3 (3%) Fail-withdrew due to treatment related AE (%) 1 (1%) 0 Late Treatment Failure (%) 3 (3%) 34 (34%) Unevaluable (%) 7 (7%) 21 (21%) Parasitological Outcome With Parasitemia on Day 1, n (%) 100 (100) 100 (100) With Parasitemia on Day 2, n (%) 96 (96) 97 (97) With Parasitemia on Day 3, n (%) 74 (74) 60 (60) With Parasitemia on Day 4, n (%) 22 (22) 21 (21) With Parasitemia on Day 8, n (%) 0 2 (2) With Parasitemia on Day 29, n (%) 3 (3) 31 (31) Without Parasitemia on Day 1, n (%) 0 0 Without Parasitemia on Day 2, n (%) 1 (1) 1 (1) Without Parasitemia on Day 3, n (%) 18 (18) 35 (35) Without Parasitemia on Day 4, n (%) 69 (69) 68 (68) Without Parasitemia on Day 8, n (%) 91 (90) 81 (81) Without Parasitemia on Day 29, n (%) 88 (88) 43 (43) Unevaluable for Parasitemia on Day 1, n (%) 0 0 Unevaluable for Parasitemia on Day 2, n (%) 3 (3) 2 (2) Unevaluable for Parasitemia on Day 3, n (%) 8 (8) 5 (5) Unevaluable for Parasitemia on Day 4, n (%) 9 (9) 11 (11) Unevaluable for Parasitemia on Day 8, n (%) 9 (9) 17 (17) Unevaluable for Parasitemia on Day 29, n (%) 9 (9) 26 (26) Molecular Analysis of Treatment Failure N 4 29 Failures due to re-infection (based on Genetic Fingerprinting) n (%) 2 (50) 15 (52) WHO Response Classification Sensitive, n (%) 87 (87) 42 (42) Resistant RI, n (%) 3 (3) 31 (31) Resistant RII, n (%) 0 2 (2) Resistant RIII, n (%) 2 (2) 4 (4) Unevaluable, n (%) 8 (8) 21 (21) Secondary Efficacy Results: Parasite Clearance Time, h N Mean (SD) 86.2 (45.0) 74.4 (43.9) Median Range Fever Clearance Time, h N Mean (SD) 54.8 (48.4) 39.7 (32.8) Median
4 Range Safety Results: On-therapy adverse events (AEs) were defined as all AEs where the onset date was on or after the first day of treatment and before or on the last day of the 26-day follow-up period. On-therapy serious adverse events (SAEs) include all serious AEs that occurred on treatment or with onset within 26 days of the end of treatment. Most Frequent Adverse Events On-Therapy N (Safety) n (%) n (%) Subjects with any AE(s) 48 (48) 43 (43) Cough 14 (14) 13 (13) Diarrhea 12 (12) 15 (15) Vomiting 7 (7) 7 (7) Respiratory Tract Infection 4 (4) 0 Sore Throat 3 (3) 0 Worms in Stool 3 (3) 0 Upper Respiratory Tract Infection 2 (2) 2 (2) Decreased Appetite 2 (2) 1 (1) Fever 2 (2) 1 (1) Constipation 2 (2) 0 Helminthiasis 2 (2) 0 Common Cold 1 (1) 4 (4) Weakness 1 (1) 4 (4) Lower Respiratory Tract Infection 1 (1) 2 (2) Fatigue 1 (1) 1 (1) Pruritus 1 (1) 1 (1) Recurrent Diarrhea 1 (1) 1 (1) Rhinitis 1 (1) 1 (1) Intestinal Helminthiasis 0 3 (3) Abdominal Pain 0 1 (1) Anemia 0 1 (1) Dehydration 0 1 (1) Dystonic Movement(s) 0 1 (1) Nausea 0 1 (1) Serious Adverse Events - On-Therapy n (%) [n considered by the investigator to be related to study medication] N (Safety) Subjects with Non-Fatal SAEs, n (%) 1 (1) 3 (3) n (%) [related] n (%) [related] Convulsions 1 (1) [0] 0 Anemia 0 1 (1) [0] Lower Respiratory Tract Infection 0 1 (1) [0] Dystonic Movement(s) 0 1 (1) [0] Subjects with Fatal SAEs 0 0 4
5 Conclusion: See publication below. Publications: Borrmann S. Faucher JF. Bagaphou T. Missinou MA. Binder RK. Pabisch S. Rezbach P. Matsiegui PB. Lell B. Miller G. Kremsner PG. Atovaquone and proguanil versus amodiaquine for the treatment of Plasmodium falciparum malaria in African infants and young children. Clinical Infectious Diseases. 37(11):1441-7, 2003 Abstract: Atovaquone and proguanil versus amodiaquine in the treatment of uncomplicated plasmodium falciparum malaria in children weighing >+5 and <11 kg in gabon. Borrmann, S, Faucher, J F, Binder, R K, Miller, G B, Lell, B, and Kremsner, P G American Society of Tropical Medicine and Hygiene 50th Annual Meeting 11/11/2001 Atlanta, GA; USA Abstract: Atovaquone and proguanil versus amodiaquine in the treatment of uncomplicated plasmodium falciparum malaria in children weighing 5 and < 11kg in gabon. Faucher, J F, Binder, R K, Lell, B, Kremsner, P G, Borrmann, S, and Miller, G B 3rd European Congress on Tropical Medicine and International Health 9/8/2002 Lisbon; Portugal Date Updated: 23-May
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