Pregnancy rates among female participants in phase I and phase IIA AIDS vaccine clinical trials in Kenya.

BACKGROUND: Female participants in AIDS candidate vaccine clinical trials must agree to use effective contraception to be enrolled into the studies, and for a specified period after vaccination, since the candidate vaccines' effects on the embryo or foetus are unknown. OBJECTIVES: To review data on female participants' pregnancy rates from phase I and IIA AIDS vaccine clinical trials conducted at the Kenya AIDS Vaccine Initiative (KAVI) and to discuss the challenges of contraception among female participants. DESIGN: Descriptive observational retrospective study. SETTING: KAVI clinical trial site, Kenyatta National Hospital and University of Nairobi, Kenya. SUBJECTS: Thirty nine female participants were enrolled into these trials. They received family planning counselling and were offered a choice of different contraceptive methods, as per the protocols. All contraception methods chosen by the participants were offered at the study site at no cost to the participant. RESULTS: Four women conceived during the study period when pregnancies were to be avoided. All four had opted for sexual abstinence as a contraceptive method, but reported having been coerced by their partners to have unprotected sexual intercourse. CONCLUSION: Abstinence is clearly not a reliable contraceptive option for women in developing-country settings. Effective female-controlled contraceptives, administered at the clinical trial site, may empower female participants to better control their fertility, leading to more complete clinical trial data.

Bronchoscopic study on aetiology of chronic cough in HIV-infected adults with negative sputum smears for Mycobacterium tuberculosis at Kenyatta National Hospital, Nairobi.

OBJECTIVE: To establish the aetiology of chronic cough in HIV-infected patients with negative sputum smears for Acid Fast Bacilli (AFB). DESIGN: A cross-sectional descriptive study. SETTING: Kenyatta National Hospital, a tertiary referral centre in Kenya SUBJECTS: Sixty five HIV-infected adults presenting with chronic cough and negative sputum smears for AFBs. RESULTS: Sixty-two patients were included in the final analysis. Aetiology of chronic cough was established in 42 (68%) patients. Pneumocystis jiroveci, bacterial pneumonia and Mycobacterium tuberculosis were diagnosed in 22 (35.5%), 17 (27.4%) and 14 (22.5%) patients respectively. Majority (98%) of patients with a diagnosis had multiple causes established in them. Ciprofloxacin had activity against 91% of the isolated organisms while Penicillin was active against 35% only. CONCLUSION: This study documents Pneumocystis jiroveci pneumonia as a common cause of morbidity in a subset of HIV infected patients with chronic cough and negative sputum smears for AFB in Kenya.

Efficacy and safety of an artesunate/mefloquine combination, (artequin) in the treatment of uncomplicated P. falciparum malaria in Kenya.

BACKGROUND: Although artesunate and mefloquine have been used as monotherapies in the treatment of malaria in Kenya for a long time, there is insufficient data on the clinical outcome when used as combination therapy in this population. OBJECTIVE: To derive data on the efficacy and safety profile of artesunate-mefloquine combination in the treatment of uncomplicated Plasmodium falciparum malaria in Kenya. DESIGN: An open label single arm clinical trial. SETTING: Bungoma district Hospital. Study area was Bungoma District of Kenya, an endemic area of malaria. The study was conducted between January 2004 and April 2004. SUBJECTS: A total of 200 males and females with uncomplicated plasmodium falciparum malaria weighing 35kg and above were recruited in the study. RESULTS: In the evaluable patient population the day 28 cure rate was 98.4% while day 14 and 7 cure rates were 98.4% and 99.2% respectively. There was rapid relief of symptoms the median time of fever clearance was one day and the most common drug related adverse events were headache dizziness and asthenia. There was no significant derangement in the haematological, biochemical and ECG parameters in the patients on treatment. CONCLUSION: Artesunate-mefloquine combination given simultaneously was found to be highly effective and safe in the treatment of uncomplicated malaria.

Diagnostic utility of cerebrospinal fluid studies in patients with clinically suspected tuberculous meningitis.

OBJECTIVE: To compare yields of cerebrospinal fluid (CSF) studies in the diagnosis of tuberculosis meningitis (TBM). DESIGN: Prospective laboratory study, Kenyatta National Hospital, Kenya. STUDY POPULATION: Consecutive patients with 1) headache, neck stiffness and altered consciousness for more than 14 days, 2) above features plus evidence of tuberculosis elsewhere in the body, and 3) on standard antimeningitic drugs for one week without response, were included. Those with contraindications to lumbar puncture, confirmed causes of meningitis (except TB) and on anti-tuberculosis treatment were excluded. METHODS: CSF cell counts, glucose and protein were assayed. CSF was stained on ZN, cultured on LJ and BACTEC and subjected to PCR and LCR for Mycobacterium tuberculosis DNA sequences. Positive tests for M. tuberculosis were classified as definite and the rest as probable TBM. RESULTS: Fifty-eight patients with a mean age of 33.0 years were recruited. Mean CSF cell count was 71/microl and CSF lymphocyte count up 67%. Mean CFS protein and glucose were 2.10 g/l and 2.05 mmol/l, respectively. BACTEC was positive in 20 cases, LJ 12, LCR eight, and PCR and ZN one each. Twenty-six patients had definite and 32 probable TBM. Patients with definite TBM had significantly higher CSF protein, lower CSF glucose, higher CSF cell count and lower CSF lymphocytes. CONCLUSION: TBM can be confirmed in half of clinically suspected cases. More sensitive tests for confirmation of TBM are required.

Anthrax revisited.

BACKGROUND: Anthrax is an ancient disease affecting animals and humans. Sporadic cases of anthrax and small epidemics have been seen from time to time in different parts of the world and in Africa. However many clinicians are not very familiar with the various presentations and management of anthrax. It is relevant for the health care workers to re-familiarise themselves with all aspects of anthrax, with the impending threat of bioterrorism. OBJECTIVE: To familiarise healthcare workers on all aspects of anthrax. STUDY SELECTION: To describe epidemiology pathogenesis, clinical features, management and prevention of anthrax including measures to take when weapons grade anthrax is suspected. DATA SYNTHESIS: Three forms of the disease are recognised, cutaneous, inhalational and intestinal. Cutaneous anthrax is the most common form. Inhalation anthrax is the most severe form of anthrax. The treatment of anthrax in most cases is penicillin, however with the threat of bioterrorism, intentional releases of anthrax spores in the environment has caused much concern. Weapons grade anthrax of more virulent strain and resistant to commonly used antibiotics is possible. CONCLUSION: In view of the different clinical presentations and outcomes it is important that health care workers re-familiarise themselves with the disease and in the event of bioterrorism are able to take appropriate measures.

Meningococcal meningitis.

Meningococcal meningitis has been recognised as serious problem for almost 200 years. In Africa the disease occurs in epidemics periodically during the hot and dry weather in the "meningitis belt" and in east Africa, which is outside this belt the epidemics tend to occur during the cold and dry months. The infection is mainly transmitted from person to person by nasopharyngeal carriers in crowded places like refugee camps and army barracks. The rural/urban migration, the basic structural conditions of housing in squatter settlements and slums together with an overcrowded transport system have also contributed to the transmission of meningococcal meningitis. The earlier treatment of meningococcal meningitis was by the way of repeated CSF drainage. The first important advance in the treatment was intrathecal injection of antimeningococcal serum. A major break through in the treatment was the introduction of sulphonamides which was the preferred treatment until emergence of resistance to sulphonamides in mid 1960's. Penicillin remains the drug of choice currently. Mass immunisation of selected communities using polyvalent A and C polysaccharide vaccine is a useful control measure. Chemoprophylaxis is generally not recommended during epidemics. Given the current population densities and rural/urban migration together with financial constraints, future epidemic in Kenya may be more explosive unless strict surveillance programmes are maintained.

Blackwater fever at the Kenyatta National Hospital in Kenya: a case report.

Blackwater fever was an important cause of morbidity and mortality in the beginning of this century particularly in West and Central Africa. There has been a marked reduction in the incidence of blackwater fever since 1950 and only sporadic cases occur nowadays. At the Kenyatta National Hospital, three cases of blackwater fever have been seen in the past four years whereas not a single case had been reported between 1975 and 1988. Two of the patients fit into the classical description of blackwater fever and one was possibly due to drug induced haemolysis in a G6PD deficiency patient.

Recurrent polyneuropathy in pregnancy: a case report.

A 33-year old female patient presented with recurrent polyneuropathy during two consecutive pregnancies and recovered completely after spontaneous abortion the first time and after a normal delivery the second time. The patient has had a tubal ligation since then and has remained well up to date.

Laboratory diagnosis of malaria -- overview.

PIP: Features of the laboratory diagnosis of malaria are described. Microscope equipment is absolutely essential. Clinical symptoms are inadequate for the proper diagnosis of malaria. Screening for malaria involves identification of all cases where high fever is present in endemic areas. Diagnosis is complicated because many people take antimalarial drugs which reduce the chances of detecting malarial parasites. Confirmation should be made before treatment is administered. A thick blood slide can be quickly and cheaply taken without much training of health personnel. The disadvantage of thick stains is the difficulty in identifying "plasmodium" strains. When a thin smear with Giemsa and Leishmanin stain is used, a light infection may be missed. Thin smears require trained personnel and time, which in peak seasons may be impractical. Urinary tract and viral infections may be confused with malaria. Evidence of parasites can be discerned from thick stains. Modern assay techniques are also available. There are enzyme linked immunosorbent assays (ELISA) and immunofluorescent assay techniques (IFAT), which are frequently used in large scale seroepidemiological studies. DNA probes have the limitation of radioisotope handling problems. Acridine orange fluorescent microscopy with capillary centrifuged blood is a technique which improves the viability of Giemsa stain procedures. This technique is desirable because of the sensitivity and speed of diagnosis. The quantitative buddy coat (GBC) technique is superior to Giemsa stained thick blood film in identifying malaria, but it is not reliable with mixed infections. Advanced techniques are not readily available in local settings. The recommendation is to continue use of thick or thin blood film and trained health personnel. Laboratory results must be interpreted in the context of when the flood film was prepared, prior drug administration, and clinical manifestations.^ieng

Laboratory diagnosis of Malaria: overview

Malaria is recognized as a serious health problem in Africa; one that has far reaching medical; social and economic consequences. In order to minimise morbidity and mortality it is important to make prompt diagnosis so that appropriate treatment can be started early

Clinical surprises and challenges of severe malaria at Kenyatta National Hospital, Kenya.

While conducting a clinical trial study from July, 1989 to February 1990, we noted with surprise some clinically challenging manifestations of severe falciparum malaria at Kenyatta National Hospital, Kenya. Of the 33 cases we studied, this paper summarises two fatal cases of malaria, one case presenting with hyperglycaemia and one with severe anaemia.

Quinine loading dose in severe Falciparum malaria at Kenyatta National Hospital, Kenya.

From July 1989 to February 1990, 17 non-pregnant patients with severe falciparum malaria, aged 14 years and above received an initial intravenous quinine dihydrochloride loading dose of 20 mg/kg in 500 mls of normal saline or 5% dextrose infused over 4 hours followed by 100mg/kg infused 8 hourly for at least 24 hours. Sixteen comparable controls were similarly treated but without an initial loading dose. Oral quinine bisulfate 10mg/kg 8 hourly was substituted for a total of 7 days when patients were well enough. There was no significant difference in clinical and parasitological response between the two groups. Fever clearance time in hours was 44.00 +/- 13.92 (mean +/- SD) in the study group and 51.43 +/- 19.63 (mean +/- SD) in the control group (p > 0.05). Parasite clearance time in hours was 42.40 +/- 9.75 (mean +/- SD) in the study group and 47.05 +/- 7.69 (mean +/- SD) in the control group (p > 0.05). One patient from each group died. Mild toxic effects were common in both groups. Transient partial hearing loss occurred significantly more in the study than control group (p < 0.05). Hypoglycaemia during treatment occurred in 3 (18%) patients in the study group and 1 (6%) in the control group. The mean trough and peak plasma quinine levels in 3 patients per group was persistently higher than 9mg/L after first infusion. We conclude that though fairly well tolerated, quinine loading dose appears to have no advantage over the standard treatment for severe falciparum malaria at Kenyatta National Hospital, Nairobi, Kenya.

Rat bite fever: a case report of a Kenyan.

Rat bite fever has not been reported from Kenya previously. A case of 17 year old Kenyan male who was diagnosed to have rat bite fever after a bite of domestic rat is described. The history, clinical features and demonstration of spirillum like organisms from a thick blood film suggest infection due to spirillum minus. The patient recovered completely after a course of penicillin and gentamicin.

Splenectomy in kala-azar.

At the beginning of the century, splenectomy was used in the treatment of kala-azar, but now is rarely needed, the major indication being for drug resistant kala-azar. Inadvertent splenectomy prior to the diagnosis of kala-azar continues to occur, probably because of a reluctance to perform splenic aspiration in the investigation of splenomegaly. Five Kenyan children underwent splenectomy for drug resistant kala-azar. All were immediately improved, but one died of overwhelming post splenectomy infection (OPSI) two months later and another of a malignant lymphoma seven months after surgery. The other three patients appear to be cured. Splenectomy was considered in a sixth child with kala-azar because of a Salmonella abscess in the spleen, but the abscess ruptured catastrophically before surgery could be arranged.